CONFIDENTIAL

ISI-FDA MEETING April 24, 2015

Background Information for April 24, 2015

Meeting between the FDA and Intuitive Surgical, Inc.

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ISI-FDA MEETING April 24, 2015

Intuitive Surgical, Inc. (ISI) greatly appreciates the opportunity to discuss with the FDA current topics of
interest regarding the da Vinci Surgical System (hereinafter da Vinci System). This document is
provided as background for the meeting between ISI and FDA representatives.
The purpose of the meeting is to open up lines of communication between ISI and FDAs postmarket
surveillance and da Vinci Working Group staff and to aid FDA in performing its postmarket surveillance
duties by:

Sharing significant postmarket clinical data on da Vinci System,

Reviewing MDR death and serious injury report rates in the context of report date vs.
occurrence date,
Reviewing unique factors that influence complaint reporting to ISI, and
Discussing most productive ways to work together in getting the Agency the postmarket
information it desires.

Provided below is an executive summary of the background information regarding the planned agenda
topics followed by a more detailed discussion.

Executive Summary

The da Vinci System was designed to address the technical limitations of conventional
laparoscopy using computation, mechatronics, 3D imaging technology, and control algorithms
to allow surgeons to apply minimally invasive surgery techniques to a broader population of
patients, and to improve the experience of minimally invasive surgery for patients and surgeons.

The da Vinci System is commonly used in the United States. The system was used in over
570,000 procedures globally in 2014.

Robust review of postmarket data includes both the analysis of MDR trends and the continuous
monitoring of clinical literature.

Large scale, high Level of Evidence studies for procedures performed using the da Vinci System
consistently demonstrated superior patient safety as compared to open and laparoscopic
surgical techniques.

Clinical literature also supports superior patient safety of the da Vinci System as
compared to open surgery independent of patient selection and surgeon experience.

Clinical literature on post-discharge readmission rates in prostatectomy and

hysterectomy supports lower readmission rates for da Vinci surgery than laparoscopic or
open surgical techniques.

Complaint reporting on da Vinci devices is unique due to the comprehensive nature of da Vinci
assisted surgery, case attendance by ISI representatives, media attention, and extensive
advertising and recruiting by the plaintiff lawyer community.

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The types of reported complications for da Vinci assisted surgery are the same as with other
types of surgery.

The complaint investigation process at ISI is thorough, timely, responsive to FDAs AI requests,
and designed to be in compliance with regulatory requirements.

ISI wishes to work collaboratively with the FDA and aid the FDAs postmarket surveillance
efforts.

Background
I.

Overview of Intuitive Surgicals da Vinci System

ISI developed the da Vinci System to satisfy a need in surgery to broaden use of minimally invasive
approaches and to improve the experience of minimally invasive surgery for patients and surgeons.
Conventional minimally invasive surgery (laparoscopy) advanced relatively quickly in minimizing
morbidity and complications in several surgical procedures, particularly those that required relatively
little surgical reconstruction (for example, cholecystectomy to treat gallbladder disease, endometriosis
resection, and so on). Application of minimally invasive techniques for more complex pathology (e.g.
surgery to treat cancer) and those procedures that require significant reconstruction (e.g. pelvic floor
reconstruction) had proceeded significantly more slowly. For example, in the year 2000, approximately
95% of all prostate cancer surgery was performed through an open incision.
The primary technical limitations of conventional laparoscopy when compared to open surgery are fourfold:

Most laparoscopic surgery is performed using a two-dimensional image, which inhibits depth
perception.
Movement of long, rigid tubular instruments in laparoscopy is subject to direction reversal due
to the pivot of the instrument at the patients body wall and surgeon tremor, which makes fine
instrument movement challenging.
Most laparoscopic instruments do not have the same freedom of motion as a human wrist
inside the body, which constrains the angles at which these instruments can approach tissue.
The challenging ergonomics associated with conventional laparoscopy can be physically
detrimental to the surgeon.

The da Vinci System was designed to address the above limitations using computation, mechatronics,
and control algorithms. The system incorporates three-dimensional digital cameras and displays to
provide an immersive 3D view of the surgical field for the surgeon, enhancing depth perception. The
system uses mechatronic arms to hold and control the instruments, and uses computational algorithms
to provide the surgeon intuitive control of these instruments. It uses tubular surgical instruments that
incorporate distal wrists that retain the patient benefits of port access while returning to the surgeon
the two degrees of freedom of their wrist that were lost in the transition from open surgery to manual
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laparoscopy. Finally, surgeons are able to operate seated in a comfortable, ergonomic position. The
combination of these improvements in visualization, wristed instruments, mechanisms, computer
control, and ergonomics increases the precision and control of the instruments compared with manual
laparoscopy. Table 1 below summarizes these key differences.

Laparoscopy Technical
Limitation

da Vinci System Solution

Benefit conferred

Two-dimensional image

Three-dimensional image

Strengthens depth perception due to

additional visual information

Counter intuitive movement

Intuitive movement afforded by

mechatronic arms and computational
algorithms

Greater precision and control at tool

tips for fine tasks like suturing and
reconstruction

Long, rigid tubular instruments

Wristed tubular instruments

Returns to surgeon the ability to reach

around structures that was lost in
transition from open surgery to
laparoscopy

Poor ergonomics

Improved ergonomics

Less neuropathies and musculoskeletal

problems from high force laparoscopic
manipulation, less mental stress and
workload

Table 1. How the da Vinci System Addresses Key Technical Limitations in Laparoscopy

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Figure 1 below shows the key system elements. The da Vinci is comprised of a Surgeons Console and
optional dual Surgeons Console (for training), a Patient Side Cart, and an Imaging System (Vision)
Tower.

Surgeons Console

Patient Cart

Vision Tower

Figure 1: da Vinci Surgical System

The da Vinci System includes:
mechatronics and computational algorithms that allow surgeons to intuitively control wristed
laparoscopic instruments,
3D imaging that displays combined left and right eye images to the surgeon, and
a suite of instruments and accessories that can perform the same surgical tasks as manual
laparoscopy (e.g. scissors, needle drivers, cautery instruments).
The da Vinci System is NOT:
an autonomous robot it does not take any surgical action on its own, nor
a clinical decision maker there is no attempt to replace surgeon judgment.
As surgical robotics was more broadly adopted, the need for key technologies available in open and
laparoscopic surgery was requested for the robotic product lines. This included vessel sealing, stapling,
and single site instrument technology (all of which have been the subject of subsequent 510(k)
clearances). The additional technology has expanded the da Vinci product offering and has allowed ISI
to better support its customers requests.

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II.

ISI-FDA MEETING April 24, 2015

Review of Postmarket Data - Summary of Significant Clinical Literature

on da Vinci Assisted Surgery

The da Vinci System is a surgical tool that can be used for a variety of surgical procedures. By the end of
2014, over 3,000 systems were in clinical use worldwide, with approximately 570,000 procedures
completed in 2014. The primary surgical specialties using the system in 2014 were gynecologic surgery,
urologic surgery, general surgery, thoracic surgery, head and neck surgery (otherwise known as
transoral robotic surgery or TORS), and cardiac surgery. The approximate breakdown in procedures for
these specialties for 2014 worldwide is shown in Table 2.

Surgical Specialty

Approximate Procedures in 2014

Total

570,000

Gynecology

252,300

Urology

173,200

General Surgery

120,660

Thoracic

11,700

Head Neck (TORS)

6,800

Cardiac

4,600

Table 2: 2014 Breakdown of Procedures by Specialty

The peer-reviewed clinical literature on the da Vinci System is extensive and diverse. There are over
8,500 peer-reviewed clinical publications on the use of the da Vinci System across many specialties and
patient populations with new publications on the da Vinci System releasing at a rate of approximately
150 per month. ISI-sponsored or supported1 research constitutes less than 1% of these publications.
There are now greater than 1,250 high Level of Evidence (LOE) comparative studies of the da Vinci
System. Clinical literature provides critical data for the ongoing surveillance of postmarket product
performance.
Analyses of the da Vinci System presented in the clinical literature span a variety of topics including
clinical outcomes, surgeon and OR staff training, and cost. The maturity of literature describing the use
of the da Vinci System varies by surgical specialty; for instance, the data for da Vinci assisted procedures
in urology and gynecology are more extensive with higher LOE as compared to general surgery in which
the da Vinci System has more recently been adopted. Therefore, much of the analysis presented here
will stem from publications2 encompassing the most mature specialties that have been well adopted in
1

ISI sponsored or supported literature refers to studies to which ISI contributed funds or data analysis support for
the study.
2
For all articles referenced in this document, full text articles are attached.

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the market and thus providing studies with large sample size and high LOE. A review of papers for
representative procedures in Thoracic, General Laparoscopy, and TORS are also included to provide the
published data supporting the safety of da Vinci for these additional general cleared indications.
The scientific LOE for clinical publications is determined based on ISIs interpretation of The Oxford
Levels of Evidence (March 2009) [1], as provided in Table 3 below.
Level
I

Sublevel
a
b
c
a

II
b
a
III

b
a

IV

n/a

Study Design
Systematic reviews of Randomized Control Trials (RCTs)
Randomized Controlled Trials (RCTs)
RCTs investigating robotic technique
Systematic reviews of comparison studies
Independent database population studies
Prospective, non-randomized studies
RCTs where N<20
Systematic reviews that incorporate both comparison and single arm studies
Retrospective comparison studies
Prospective, non-randomized studies where N<20
Literature reviews
Single arm studies
Retrospective comparison studies where N<20
Case reports (i.e. single arm studies where N<20)
Animal and cadaver studies
Bench research
Expert opinions and editorials

Table 3: Scientific Level of Evidence (LOE) for Clinical Publications

As discussed more fully below, the data consistently demonstrated that use of the da Vinci System
compares favorably to both open and laparoscopic surgery across a variety of measures, including
complication and readmission rates.

Overall Safety and Effectiveness of the da Vinci System as Compared to Open and Laparoscopic
Surgical Techniques
Prostatectomy To date, there are approximately 1,900 peer-reviewed publications examining use of
the da Vinci System in prostatectomy procedures. Of these, more than 450 studies compare da Vinci
assisted prostatectomy with other surgical techniques. Due to very low adoption of laparoscopic
surgery for prostatectomy in the United States, there is limited literature comparing da Vinci assisted
surgery to laparoscopic surgery, and is instead predominantly compared to open surgery.
Safety and effectiveness in prostatectomy procedures are summarized below with respect to the
following parameters: length of stay, readmission rate, mortality rate, overall complication rate, urinary

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incontinence rate, erectile dysfunction rate, positive surgical margin rate (cancer), blood transfusion
rate, and operative time.
Overall Summary of Prostatectomy Data
Data from the larger and higher LOE studies comparing da Vinci assisted prostatectomy with
open prostatectomy demonstrate that use of the da Vinci System in prostatectomy is superior
to open surgery in key measures of safety and effectiveness:

Reduced rate of blood transfusions [2-11]

Reduced length of stay [3-7, 10, 11]
Lower mortality rate [3, 5, 6, 10]
Fewer overall complications [2, 3, 5-7, 9-11]
Reduced rate of urinary incontinence [7, 12]
Reduced rate of erectile dysfunction [7, 13]
Lower overall and T2 positive surgical margin rate [7, 10]

Some of these studies also indicate a longer operative time to perform a da Vinci assisted
Prostatectomy compared to open surgery:
Longer Operative Time [3, 6, 7, 9]
Detailed analysis
A complete review of the large set of comparative prostatectomy studies was conducted, and is
summarized below in Table 4. Two of the largest database studies with strong LOE were
completed by Kowalczyk [5] and Liu [6] on the clinical outcomes of prostatectomy using the da
Vinci System. These studies demonstrate that, while use of the da Vinci System increased
operative time compared to open prostatectomy by averages ranging from 15.8 to 60 minutes,
da Vinci assisted prostatectomy was definitively safer than the open surgery it replaced with
respect to the key measures summarized above. Effectiveness was also improved relative to
open surgery as demonstrated by lower average overall positive surgical margin rates [10],
lower T2 positive margin rates [7, 10], improved urinary continence [7, 12], and improved
erectile function [7, 13]. Results from these studies are consistent with results demonstrated in
the extended body of literature on da Vinci use in prostatectomy and are summarized in Table 4
and Table 5.

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Key Safety
Parameters

Study Details

Overall
complication rate*

Readmission rate

Transfusion rate

Mortality (30 days)

Length of Stay

Operative Time

ISI-FDA MEETING April 24, 2015

2013 Davis[3]
LOE (IIa)

N=57,472
Premier
Database
(ISI provided
data analysis)

2013
Pilecki[9]
LOE (IIa)

2013
Moran[7]
LOE (IIa)

2012 Tewari[10]
LOE (IIa)

N=5,471
NSQIP
Database
(Independent
of ISI)

Systematic
Review
9-20 studies
(Independent
of ISI)

Systematic
Review
400 studies
(ISI provided
data analysis)

10.6% vs.
15.8%
(p <0.0001)

5.62% vs.
23.25%
(p <0.001)

da Vinci rate
26% less than
open
(p =0.047)

NR

3.48% vs.
5.47%
(p =0.002)

NR

1.87% vs.
17.68%
(p <0.001)
0.14% vs.
0.27%

2.3% vs.
11.5%
(p <0.0001)
0.03% vs.
0.09%
(p < 0.0066)
2.2 days vs. 3.4
days
(p <0.0001)
4.4 hrs vs.
3.4 hrs
(p <0.0001)

NR

212 min vs.

174 min
(p <0.001)

IntraOp:
0.4% vs. 1.5%
(p =0.005)

2012
Novarra[8]
LOE (IIa)

2009 Hu[4]
LOE (IIa)

2011
Kowalczyk[5]
LOE (IIa)

2012 Trinh[11]
LOE (IIa)

10

2013 Liu[6]
LOE (IIa)

2014 OHTAC HTA[2]

LOE (IIa)

Systematic
Ontario HTA Population based,
N=8,837
N=78,232
N=14,987
N=5319
Review
retrospective cohort study
SEER Database CMS Database CMS Database NSQIP Database
110 studies
design
(Independent of (Independent of (Independent of (Independent of
(Independent
(Independent of ISI)
ISI)
ISI)
ISI)
ISI)
of ISI)

da Vinci rate
20% less than
open

21.9% vs.
23.4%

PeriOp:
19.6% vs.
29.8%
(p <0.001)

9.3% vs.
11.1%
(p <0.001)

4.98% vs.
9.04%
(p <0.0001)

Patients who underwent RARP

had significantly fewer
complications, according to a
composite measure(p <0.001)

3.5% vs. 3.0%

NR

NR

NR

NR

NR

NR

da Vinci rate
77% less than
open
(p <0.001)

1.8% vs.
16.5%
(p <0.001)

da Vinci rate
86% less than
open
(p <0.0001)

2.5% vs.
20.1%
(p <0.001)

2.6% vs.
17.3%
(p <0.001)

2.4% vs.
7.7%
(p <0.001)

1.3% vs.
21.3%
(p <0.0001)

0.8% vs.
11.4%
(p <0.001)

NR

0.04% vs.
0.10%
(p =0.02)

NR

NR

0.2% vs.
0.6%
(p <0.001)

0.0% vs.
0.1%

0.05% vs.
0.39%
(p =0.01)

NR

1.4 days
3.1 days
(USA)
(p <0.001)

NR

2 days vs.
3 days
(p <0.001)

2 days vs.
4.2 days
(p <0.001)

LOS > 2 days

14.5% vs.
39.6%
(p <0.001)

1.8 days vs.

3.2 days
(p <0.001)

NR

NR

da Vinci15.8
min more
than open

NR

NR

NR

211 min vs.

190 min
(p <0.001)

NR

da Vinci0.7
days shorter
than Open
(p =0.006)
da Vinci37
min more
than open
(p <0.001)

PeriOp:
7.8% vs. 17.9%
(p <0.001)

Table 4: Comparison of safety da Vinci vs. open prostatectomy reported in large, high LOE clinical literature. Note: Blue text designates data
related to da Vinci assisted Prostatectomy. Colored cells denote
FOIstatistically
Exempt significant differences; green signifies statistical significance in
favor of da Vinci, yellow signifies statistical significance in favor of open surgery.

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2013 Davis
2013
Davis[3]
LOE (IIa)

Study Details

N=57,472
Premier
Database
(ISI provided
data analysis)

Length of Stay

2.2 days vs.

3.4 days*
(USA)
(p <0.0001)

Positive Surgical
Margin

NR

2012 Novarra,

Key
Effectiveness
Parameters

2013 Pilecki
2013 Pilecki[9]
LOE (IIa)

2013 Moran
2013 Moran[7]
LOE (IIa)

2012 Tewari
2012 Tewari[10]
LOE (IIa)

11,12,13

Ficarra
2012 Novara,
Ficarra[12-14]
LOE (IIa)

N=5,471
NSQIP Database
(Independent of
ISI)

Systematic Review
9-20 studies
(Independent of
ISI)

Systematic Review
400 studies
(ISI provided data
analysis)

NR

da Vinci LOS 0.7

days shorter
than Open*
(p =0.006)

1.4 days
3.1 days*
(USA)
(p <0.0001)

NR

Overall PSM*
16.2% vs
24.2%*
(p <0.0001)

Overall PSM
da Vinci rate
17.4% less than
open

pT2 PSM*
10.7% vs
16.6%*
(p <0.0001)

pT2 PSM
Open rate is
1.25x higher than
da Vinci

NR

pT2 PSM
da Vinci rate 37%
less than open*
(p <0.001)

Systematic Review
110 studies
(Independent of ISI)

da Vinci rate 1.6x

da Vinci rate
higher than
2.84x higher than
NR
NR
NR
open*
open*
(p <0.001)
(p =0.002)
da Vinci rate 6%
da Vinci rate 1.53x
Continence
higher than
NR
NR
NR
higher than open*
(12 month)
open*
(p =0.03)
(p =0.009)
Table 5: Comparison of surgical outcomes da Vinci vs. open prostatectomy reported in large, high
LOE clinical literature. Note: Blue text designates data related to da Vinci assisted Prostatectomy.
Colored cells denote statistically significant differences; green signifies statistical significance in favor
of da Vinci, yellow signifies statistical significance in favor of open surgery.
Potency
(12 month)

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Hysterectomy To date, there are approximately 420 cancer hysterectomy and 195 benign
hysterectomy peer-reviewed publications examining use of the da Vinci System in hysterectomy
procedures. Of these, more than 125 cancer and 60 benign studies compared da Vinci assisted
hysterectomy with other surgical methods (e.g. open, laparoscopic).
Safety and effectiveness in hysterectomy procedures are summarized below with respect to the
following parameters: length of stay (total and prolonged), readmission rate, complication rate, blood
transfusion rate, conversion rate, and operative time.
Overall summary of the data
Hysterectomy for Cancer- Data from larger and higher LOE studies comparing da Vinci assisted
cancer hysterectomy with open surgery demonstrate that use of the da Vinci System in cancer
hysterectomy is superior to open surgery in the following key measures of safety:

Fewer complications [15, 16]

Fewer blood transfusions [17]
Shorter length of stay [15, 18, 19]

These studies also indicate a longer operative time to perform a da Vinci assisted cancer
hysterectomy than open surgery:

Longer operative time [15, 16, 19, 20]

The longer operative time was not associated with an increased complication rate. As noted
above, there were actually fewer complications in the da Vinci group.

Hysterectomy for Benign Conditions - Data from large and high LOE studies comparing da Vinci
benign hysterectomy with open and laparoscopic surgery demonstrated that use of the da Vinci
System in benign hysterectomy is superior to open and laparoscopic surgery in several key
measures of safety and effectiveness:
da Vinci versus Open

da Vinci versus Laparoscopic

Fewer complications [15, 21-25]

Fewer re-admissions at 30 days [23]
Fewer blood transfusions [15, 21,
22, 24]
Shorter length of stay [15, 21-25]

Fewer complications [22, 23, 26]

Fewer re-admissions at 30 days [23]
Fewer conversions to open surgery [21, 22,
26]

These studies also indicate an equivalent or longer operative time to perform a da Vinci benign
hysterectomy as follows:

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da Vinci versus Open

Longer operative time[15, 21, 22,

25]

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da Vinci versus Laparoscopic

Varied differences in operative time

Detailed analysis Hysterectomy (for Cancer or Benign conditions)

A thorough review of the large set of comparative hysterectomy studies was conducted, as
summarized below in Tables 6 - 8. The largest of these studies, by Luciano [22], involved use of
a national database (Premier) and large sample size (N=289,875). The study demonstrated that
while use of the da Vinci System increased operative time compared to open and laparoscopic
benign hysterectomy, da Vinci assisted hysterectomy was definitively safer with respect to the
key measures of complication rate (open and laparoscopic), blood transfusion rate (open),
length of stay (open), and rate of conversion to open (laparoscopic). The data are consistent
with the results of the next largest study, by Martino [23] et al., which demonstrated that
patients who underwent a da Vinci assisted hysterectomy were less likely to be readmitted
within 30 days as compared to open (1.0% vs. 3.5%) and laparoscopic (1.0% vs. 2.58%)
hysterectomy. Results from these studies are consistent with results demonstrated in the
extended body of literature on da Vinci used in hysterectomy.

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2011
OSullivan[1
5]
(mixed
benign,
cancer)
LOE (IIa)

Key Safety
Parameters

2010
Matthews[2
4]
LOE (IIIb)

2011
Landeen[21]
LOE (IIIb)

Study Details

N = 277
Single
Institution
(Independent
of ISI)

N = 843
Single
Institution
(ISI sponsored
study)

N=1,795
Single
Institution
(Independent
of ISI)

N=468
Single
Institution
(Independent
of ISI)

Ireland HTA
Systematic
Review
17-22 studies
(Independent
of ISI)

Overall
complication rate*

4.29% vs.
23.04%
(p <0.0001)

8.1% vs.
14.0%
(p =0.018)

Readmission
Rate
1.0% vs.
3.5%
(p <0.001)

Intra-Op
Comps
7.7% vs.
13.7%
(p =0.04)

da Vinci rate
60% lower
(p <0.0001)

0% vs.
7.4%
(p =0.04)

0.7% vs.
2.9%
(p =0.015)

NR

5.98% vs.
7.26%

da Vinci rate
77% lower
(p <0.0001)

Transfusion rate

2013
Martino[23]
LOE (IIIb)

2014
Woelk[25]
LOE (IIIb)

2014
Luciano[22]
LOE (IIa)

N=289,875
Premier
Database
(ISI provided
data analysis)

14.8% vs.
28.9%
(p <0.001)

1.9% vs.
7.66%
(p <0.001)

da Vinci LOS
1.5 vs.
1.3 vs.
0.44 vs.
1 vs.
2.6 days
1.8 vs.
Length of Stay
3.5
2.7
0.95
3
shorter than
3.5
(days)
(p <0.0001)
(p <0.0001)
(p <0.05)
(p <0.001)
open
(p <0.001)
(p <0.0001)
da Vinci
117min vs.
3.0 hr vs.
time 49 min
3.39 hr vs.
Operative Time
NR
83min
NR
1.8 hr
longer than
2.46 hr
(p <0.0001)
(p <0.001)
open
(p <0.001)
(p <0.0001)
Table 6: Comparison of surgical safety da Vinci vs. open benign hysterectomy reported in large, high
LOE clinical literature. Note: Blue text designates data related to da Vinci assisted Hysterectomy.
Colored cells denote statistically significant differences; green signifies statistical significance in favor
of da Vinci, yellow signifies statistical significance in favor of open surgery.

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Key Safety
Parameters

2011
Scandola[26]
LOE (IIa)

2013
Rosero[17]
LOE (IIa)

Study Details

Systematic
Review
21 comparison
studies
(Independent
of ISI)

n = 15,576
NIS Database
Propensity
matched
(Independent
of ISI)

Overall
complication
rate*

2013
Wright[27]
LOE (IIa)

2011
2014
Landeen[21] Luciano[22]
LOE (IIIb)
LOE (IIa)

n = 9942
Premier
Database
Independent
of ISI

N=1,795
Single
Institution
(Independent
of ISI)

N = 843
Single
Institution
(ISI
sponsored
study)

N=289,875
Premier
Database
(ISI provided
data analysis)

8.80% vs.
8.85%

5.5% vs.
5.3%

Readmission
Rate
1.00% vs.
2.58%
(p =0.004)

8.1% vs.
8.8%

14.8% vs.
18.6%
(p <0.001)

2.1% vs.
3.1%
(p <0.001)

1.4% vs. 1.8%

NR

0.7% vs.
1.3%

1.9% vs.
2.1%
2.5 vs.
7.2
(p <0.001)

PostOp
Comps
Lap rate 1.8x
higher than da
Vinci

2013
Martino[23]
LOE (IIa)

(p <0.05)
Transfusion
rate

NR

Conversion
rate

Lap rate 2.0x

higher than
da Vinci
(p <0.05)

NR

NR

NR

0.9 vs.
3.9
(p =0.013)

Mortality
rate

NR

NR

0% vs
0%

NR

NR

0.02% vs.
0.03%

Operative
Time

da Vinci time
34% longer
than open

NR

117 min vs.

118 min

3.39 hr vs.
2.74 hr
(p <0.001)

NR

NR

Table 7: Comparison of surgical safety da Vinci vs. laparoscopic benign hysterectomy reported in
large, high LOE clinical literature. Note: Blue text designates data related to da Vinci assisted
Hysterectomy. Colored cells denote statistically significant differences; green signifies statistical
significance in favor of da Vinci, yellow signifies statistical significance in favor of laparoscopic surgery.

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Key Safety
Parameters

2010 Gaia[20]
LOE (IIa)

Study Details

Meta analysis
8 studies

2010 Reza[16]
LOE (IIa)

Meta analysis
22 studies

2011
OSullivan[15]
(mixed benign and
cancer)
LOE (IIa)
Ireland HTA
Systematic review
17-22 studies

2012 Geetha[18]
LOE (IIa)

2012 ONeill[19]
LOE (IIa)

Meta analysis
12 studies

Meta analysis
21 studies

(Independent of
ISI)

(Independent of
ISI)

da Vinci rate
41% lower than
open

(Independent
of ISI)

(Independent of ISI)

Overall
complication
rate*

Wound
Comps
1.8% vs.
13.7%
(p =0.01)

da Vinci rate 78%

lower than open
(p <0.001)

da Vinci rate 60%

lower than open
(p <0.0001)

Non-infections
morbidity
2.38%
18.5%
(p =0.005)

Transfusion
rate

1.7% vs.
7.2%

da Vinci rate 75%

less than open
(p <0.001)

da Vinci rate 80%

lower than open
(p <0.0001)

0.0% vs.
25.0%
(p <0.0001)

NR

NR

da Vinci LOS 2.6

days shorter than
open
(p <0.0001)

2.65 days vs.

7.5 days
(p =0.004)

207 min vs.

130 min
(p <0.005)

Cervical Cancer da
Vinci time 31 min
longer than open
(Not Significant)
Endo Staging
da Vinci time 89 min
longer than open
(p <0.05)

da Vinci time 49
min longer than
open
(p <0.0001)

Length of Stay

Operative
Time

(Independent of ISI)

238 min vs.

221 min

da Vinci rate
83% lower than
open
(p <0.01)
da Vinci 3.4
days less than
open
(p <0.01)

da Vinci time 42
min longer than
open
(p =0.03)

Table 8: Comparison of surgical safety da Vinci vs. open cancer hysterectomy reported in large, high
LOE clinical literature. Note: Blue text designates data related to da Vinci assisted Hysterectomy.
Colored cells denote statistically significant differences; green signifies statistical significance in favor
of da Vinci, yellow signifies statistical significance in favor of open surgery.

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Additional Surgical Safety Data (draft manuscript, pending submission)

To further investigate complication rates, data from the Premier Database for hysterectomy procedures
for benign indications using open, vaginal, laparoscopic, and da Vinci assisted surgical techniques
performed over a 6 year period (2008-2013) were analyzed for demographic and clinical information as
well as perioperative outcomes for a total of 386,991 procedures. This analysis was performed by ISI
and the data are not yet published. The outcomes reported include perioperative information from the
hysterectomy procedure and initial hospitalization only; no post-discharge complications or
readmissions are included. Overall, da Vinci surgery had statistically significant fewer complications
versus open and laparoscopic methods, as summarized below. There were no statistically significant
differences in favor of the other surgical techniques over da Vinci assisted surgery.
da Vinci versus Open

da Vinci versus Laparoscopic

Fewer Intra-op complications

Fewer Intra-op transfusions
Fewer Post-op complications
Fewer Post-op transfusions

Fewer Intra-op complications

Fewer Intra-op transfusions
Fewer Post-op complications
Fewer Post-op transfusions

20
18
16

Rate (%)

14
12
Open (N=148,296)

10

Laparoscopic (N= 154,907)

da Vinci (N= 83,788)

6
4
2
0
Intra Op CompIntra Op Blood Post Op Comp Post Op Blood
Transfusions
Transfusions

Figure 2: Comparison of surgical safety da Vinci vs. open and laparoscopic benign
hysterectomy in a large database review pending submission

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Conclusion Overall safety and effectiveness of da Vinci Surgery is equivalent or better than
open and laparoscopic surgical approaches, as demonstrated by large and high LOE studies.
Surgical Safety Data in Additional Procedures
Thoracic - In 2013, Kent et al. [28] published a scientific LOE IIa study in the Annals of Thoracic
Surgery comparing Open Surgery, Video Assisted Thoracic Surgery (VATS) and da Vinci assisted
thoracic surgery. The data used in the analysis were pulled from the HCUP SID database and
included an analysis of a propensity matched patient cohort that included n=1,233 for each
Open and VATS surgical approaches and n=411 for da Vinci assisted surgery. As seen in Figure 3
below, da Vinci assisted thoracic surgery showed statistically significant better results over open
thoracic surgery relating to lower mortality rate (p=0.016), lower overall complication rate
(p=0.003), shorter length of stay (p<0.0001) and reduced prolonged length of stay (p=0.003).
There was no statistical difference between bleeding complications for da Vinci assisted thoracic
surgery versus open surgery. Further, when the results of da Vinci assisted thoracic surgery was
compared to VATS, there were no statistically significant differences in mortality, length of stay,
prolonged length of stay, overall complications or bleeding complications. The results
demonstrated that da Vinci assisted thoracic surgery is a safer alternative than open thoracic
surgery and has a similar safety profile to VATS.

60
Open (n=1,233)

50

VATS (n=1,233)
40

da Vinci (n=411)

30
20
10
0
Mortality (%)

LOS (days)

Prolonged LOS
Any
Bleeding
(%)
Complication Complication
(%)
(%)

Figure 3: Comparison of complication rates da Vinci assisted thoracic surgery versus open
and VATS surgical methods (Kent et al., HCUP SID database, level IIa, independent of ISI)

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General Laparoscopy (Colorectal) In 2014, Xiong[29] et al published a meta-analysis in Journal

of Gastrointestinal Surgery comparing da Vinci assisted total mesorectal excision for rectal
cancer (RTME) to laparoscopic (LTME). Eight studies were identified that included 1229 patients
in total, 554 (45.08 %) in the RTME group and 675 (54.92 %) in the LTME group. Compared with
LTME, RTME was associated with lower conversion rate (p=.0004), lower positive rate of
circumferential resection margins (p=.04) and lesser incidence of erectile dysfunction (p=.02).
Operation time, estimated blood loss, recovery outcome, postoperative morbidity and
mortality, length of hospital stay, number of lymph nodes harvested, distal resection margin
(DRM), proximal resection margin (PRM), and local recurrence had no significant differences
between the two groups. The results demonstrated that da Vinci assisted rectal surgery has
improved outcomes than laparoscopy with a similar safety profile.

Table 9: Summary of primary outcomes da Vinci assisted rectal surgery (RTME) versus
laparoscopic surgical methods (LTME) (Xiong et al., level IIa, independent of ISI)

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Trans Oral Robotic Surgery (TORS) - In 2014, M Chen et al. [30] published a scientific LOE IIa
study in Otolaryngology Head and Neck Surgery comparing open trans oral surgery for
oropharyngeal cancer versus TORS. The data used in the analysis were pulled from the NCDB
database and included n=4,269 for open and n=877 for TORS. As seen in Figure 4 below, The
TORS approach showed a statistically significant reduction in positive margin for TORS versus
open surgery (p<0.001). There was a statistically significant increase in length of stay (p<0.001)
for TORS versus the open surgical approach and no statistical difference in unplanned
readmissions. The increase in length of stay is potentially due to more patients in the TORS
group having neck dissections as compared to the open group (80% vs 60%).
35.0
30.0
25.0
20.0
Open (n=4,269)

15.0

TORS (n=877)
10.0
5.0
0.0
Positive Margin
Unplanned
(%)*
Readmissions (%)

Length of Stay
(days)*

Figure 4: Comparison of positive margins, readmissions and length of stay TORS versus open
oral surgery for oropharyngeal cancer (M Chen et al., n=5,146, level IIa, independent of ISI)

To further address FDAs prior AI requests in response to MDRs reports, data related to patient
comorbidities, readmission rates and complication rates as related to surgeon experience are reviewed
below.
Clinical study with a propensity matched patient cohort shows lower complication rates for da Vinci
assisted prostatectomy compared to open
As patient attributes and comorbidities can contribute to morbidity and mortality following
surgery, in 2011, Trinh et. al.(8) al. [11] published findings from a propensity matched patient
cohort study, comparing perioperative complications between da Vinci assisted and open radical
prostatectomy in patients with well documented demographic and comorbidity information
from the Nationwide Inpatient Sample (NIS). The demographic and clinical information analyzed
included: age, race, and Charlson Comorbidity index (CCI), which predicts the ten-year mortality
for a patient with a range of comorbidities. Hospital characteristics such as academic status,
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location (urban or rural), and median annual caseload were also reported. Both cohorts were
propensity score matched by patient characteristics (age, race, CCI, year of surgery, and
insurance status) and by hospital characteristics (volume, location, region, and academic status).
Post propensity score matching, the open and da Vinci patient cohorts were similar with respect
to age and CCI, and the standardized differences between the two groups in patient and hospital
characteristics were <10%. The study found a statistically lower rate of transfusion, length of
stay beyond 2 days, overall complications, and death in patients who underwent da Vinci
assisted prostatectomy than patients who had open surgery, as shown in Figure 5.

45.00
39.60

da Vinci (n=7598)
40.00

Open (n=7389)

35.00

25.00

20.00

0.10

0.00

2.00

10.00

5.00

8.20

7.70

15.00

11.10

12.90

Rate (%)

30.00

0.00
Transfusion

LOS >2 days

Overall complications

Mortality

Figure 5: Comparison of safety da Vinci vs. open radical prostatectomy (n=14,987 propensity
score matched patients, Nationwide Inpatient Sample, IIa, independent of ISI)
The authors acknowledge in the discussion that differences between patients who undergo da
Vinci assisted and open prostatectomy relating to the disparities in access to da Vinci assisted
surgery was outside the scope of the paper. Still, they conclude in a broadly representative
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sample, perioperative outcomes were superior in the da Vinci assisted cohort for key measures
of safety including blood transfusion rate, prolonged length of stay (> 2 days), overall
postoperative complication rate, and mortality rate.
Clinical studies support lower readmission rates for da Vinci surgery in comparison to open and
laparoscopic surgery
Prostatectomy - Pilecki[9]: In 2013, Pilecki et al. published a scientific LOE IIa study in the Journal
of Endourology comparing, among others, rates of readmission within 30 days and overall
complications of da Vinci assisted vs. open surgery for radical prostatectomy. The data used in
the analysis were pulled from the NSQIP database and included a large sample size (n=5,471)
across multiple institutions.
The study found statistically lower rates of readmission within 30 days and overall complications
in procedures completed with da Vinci compared to open surgery, as shown in Figure 6.

25

Rate (%)

20
15

da Vinci
(n=4374)

10

Open
(n=1097)

5
0
Readmission
<30 days

Overall Complication

Figure 6: Comparison of readmission and overall complication rates da Vinci vs. open
prostatectomy (n=5,471, NSQIP database, level IIa, independent of ISI)
Hysterectomy - Martino [23]: In a 2014 study of 2,554 patients published in the Journal of
Minimally Invasive Gynecology by Martino et al., use of the da Vinci System was associated with
a lower readmission rate within 30 days compared to open abdominal, vaginal, and laparoscopic
methods of hysterectomy (Figure 7).

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3.5

3
da Vinci
(n=601)

2.5

Laparoscopic
(n=427)

Open
(n=1194)

1.5

Vaginal
(n=332)

0.5

0
da Vinci
(n=601)

Laparoscopic
(n=427)

Open
(n=1194)

Vaginal
(n=332)

Figure 7: da Vinci Hysterectomy reduced readmission rate over open, laparoscopic and
vaginal (n=2,554, Single institution retrospective, IIIb, independent of ISI)

Conclusion: Studies published in the prostatectomy and hysterectomy clinical literature indicate
use of the da Vinci System is associated with lower rates of hospital readmission than open and
laparoscopic surgery.
Clinical Studies show fewer complications during the learning phase of da Vinci surgeons as compared
to complication rates of experienced surgeons using other surgical approaches
Prostatectomy - Using an outcomes database (Premier the same database used by Wright et.
al. JAMA[27]), surgeons and ISI evaluated the prevalence of complications as a function of the
introduction of the da Vinci System into surgical practice in prostatectomy and hysterectomy.
Given the maturity of prostatectomy using the da Vinci System, this procedure was studied first.
In an article published in the Journal of Endourology by Davis [3] and ISI, the authors found that
surgeons have fewer complications in their early da Vinci experience than surgeons with mature
experience performing open surgery. Figure 8 below shows the complication rate of learning
surgeons using da Vinci compared to surgeons with mature experience performing open
surgery. The evidence supports that the first cases using da Vinci in prostatectomy are
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associated with fewer complications than open surgeries performed by surgeons with mature
experience. This supports our view that training on the da Vinci System is effective and that da
Vinci can offer benefits to patients, even when the surgeon is early in the learning curve.

Da Vinci Complication Rate by Increasing Experience

Complication rate

Mature Open Complication Rate

16%
15%
14%
13%
12%
11%
10%
9%
8%
7%
6%
1-25

26-50

51-75

76-100

101-125

126-150

Groups of cases

Figure 8: Complication Rates for Learning Surgeons using da Vinci Compared with Experienced
Surgeons Performing Open Prostatectomy

Hysterectomy - A similar analysis using the Premier Database was performed by Luciano [22]
and ISI evaluating complications of hysterectomy when surgeons are early in their da Vinci
experience compared to experienced surgeons performing open hysterectomy, laparoscopic
hysterectomy, and vaginal hysterectomy. The authors found that complications after
hysterectomy were lower for da Vinci surgery than any other surgical technique. Figure 9 below
shows the complication rate for hysterectomy with surgeons early use of da Vinci compared to
experienced surgeons performing open surgery, laparoscopy, and vaginal surgery. The evidence
supports that the first cases using da Vinci in hysterectomy are associated with fewer
complications and conversions than experienced surgeons performing any of the alternative
surgical approaches. Again, this analysis supports the view that training on the da Vinci System
is effective and that da Vinci assisted procedures can offer benefits to patients, even when the
surgeon is early in the learning curve.

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Figure 9: Learning Curve Measures as a Function of da Vinci Surgery Experience

Bars are da Vinci rates or time by experience tranche (legend above, e.g., 1-25 cases,
26-50 cases, etc.)
The horizontal lines are measures for laparoscopy, open surgery and vaginal surgery,
as applicable, performed by experienced surgeons
Conversion means the rate of conversion from the intended approach (lap or da Vinci)
to open surgery

Conclusion: The results of these two studies indicate use of the da Vinci System is associated
with lower complication rates and (where applicable) conversion rates than the alternative
surgical approaches, irrespective of where a surgeon is on the learning curve for the da Vinci
System.

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III.

ISI-FDA MEETING April 24, 2015

Review of Postmarket Data - Unique Factors that Influence Complaints

to ISI

There are unique factors that influence complaint reporting to ISI. These key factors are summarized
below.
1) The comprehensive nature of the da Vinci System
ISI provides institutions with a broad product suite that includes cameras, instruments,
accessories, system hardware and software, along with extensive product training. In many
institutions it has become commonplace to refer to da Vinci surgery and non-da Vinci
surgery. As a result, when da Vinci is used in surgery, there is a strong association between the
devices and the procedure, which we believe results in more communication to the company
about issues encountered, regardless of whether a product malfunctioned or there was a causal
or contributory relationship between the device and the adverse event.
2) The da Vinci System brand recognition
Open and laparoscopic surgeries are performed with an assortment of devices from various
manufacturers. Thus, we believe that adverse events that occur in open or laparoscopic surgery
are much less likely to be reported to the manufacturer unless specifically related to that
manufacturer's product (e.g. a stapler that misfired). For example, consider two equivalent
cases of ureteral injury during a hysterectomy, one using da Vinci and one using laparoscopic
instruments. In both cases, there is no evidence that the devices either caused or contributed
to the injury, however it is likely that ISI would receive a report of the adverse event and
subsequently file it as an MDR. In contrast, it is likely that none of the manufacturers of the
multiple devices used in the laparoscopic procedure would be informed of the adverse event.
3) The significant campaign for da Vinci plaintiff recruitment
In 2013, ISI received a significant increase in legal complaints (complaints received from
plaintiffs attorneys), due to an aggressive ad campaign promoted towards all da Vinci patients.
This activity resulted in thousands of unsubstantiated claims reported into ISIs Postmarket
Surveillance team (see Figure 10 below). Due to the nature of these claims including limited
patient and event information provided by the attorneys, hospitals and surgeons unable to
provide further information due to pending litigation, and the MDR reporting timeline these
events were reported as MDRs since ISI did not have sufficient information to rule out a causal
or contributory relationship of the da Vinci System. To date, greater than two-thirds of these
cases have been voluntarily withdrawn by plaintiffs counsel on the grounds that they were nonmeritorious.

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Figure 10: Chart reflecting the top 3 reporters of Serious Injury and Death MDR reports from
2011-2014
4) Case attendance and reporting by ISI representatives
On a daily basis, ISI representatives attend da Vinci assisted surgeries and are onsite at hospitals
to provide support. All ISI representatives are provided training on complaint handling and are
required to report any adverse event to the Postmarket Surveillance department as soon as
possible, regardless of whether the surgeon complained or suggested that the da Vinci System
caused or contributed to the event. Due to ISIs diligence in training and complaint reporting
awareness, combined with the daily onsite interactions at hospitals, ISI receives complaint
reports (including adverse events) from field representatives more often than hospitals or
health professionals (see Figure 10 above).
Due to the above noted unique factors, ISI believes that there is an increased likelihood that an adverse
event not directly related to a product problem will be reported to ISI after a da Vinci assisted procedure
as compared to a company associated with laparoscopic or open surgical devices. This places ISI in a
unique position with respect to receipt of reports of adverse events. We believe this difference in the
nature of complaint reporting to ISI does not derive from an inherent difference in device safety, as
evidenced by the summary of the clinical literature discussed above. Based on the below excerpt from
FDAs MAUDE database search page, ISI believes that FDA understands that there can be unique factors
that influence complaint reporting, and therefore, that MDR data alone is not sufficient to establish
rates of events or compare event rates between devices.
Although MDRs are a valuable source of information, this passive surveillance system has
limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or
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biased data. In addition, the incidence or prevalence of an event cannot be determined from this
reporting system alone due to potential under-reporting of events and lack of information about
frequency of device use. Because of this, MDRs comprise only one of the FDA's several important
postmarket surveillance data sources.

MDR data alone cannot be used to establish rates of events, evaluate a change in event
rates over time or compare event rates between devices. The number of reports cannot be
interpreted or used in isolation to reach conclusions about the existence, severity, or
frequency of problems associated with devices.
Confirming whether a device actually caused a specific event can be difficult based solely on
information provided in a given report. Establishing a cause-and-effect relationship is
especially difficult if circumstances surrounding the event have not been verified or if the
device in question has not been directly evaluated.

MAUDE data does not represent all known safety information for a reported medical device and
should be interpreted in the context of other available information when making device-related or
treatment decisions.

IV.

Review of Postmarket Data - MDR Data

ISI reviews all complaint and MDR data on a regular basis to look for trends or anomalies related to its
devices, procedure types, and other details of the events that may impact patient safety or product
quality. The number of individual Serious Injury and Death MDRs has increased due to the growing
volume of da Vinci assisted surgical procedures being performed worldwide. In addition, in 2013 there
was a dramatic increase in the number of MDRs filed as a result of complaints that were received from
plaintiffs attorneys (see Figure 10 and above discussion).
From 2013 to date, ISI has received over 3,500 attorney-sourced claims of events that have been
reported to the FDA as serious injuries. Greater than 99% of these claims have no product malfunction
allegation and of the 1% that have product allegation, these allegations have not been substantiated.
The claims are all for known complications of the given surgery.
The chart provided in Figure 11 below reflects the percentage of Serious Injury and Death MDRs
reported from 2011-2014 by the number of da Vinci assisted surgical procedures completed in that
same time frame. Importantly, this is presented by both report date and by event date. The large
increase of Serious Injury reports in 2013, when assessed by report date (red line in Figure 11), is solely
attributed to legal claims. When the same data are analyzed by the event date (purple line in Figure 11),
it can be seen that the significant spike in 2013 disappears.
To accurately evaluate device safety over time, the MDR trend data are best analyzed by event date and
not report date. When MDR serious injury and death data are analyzed by event date for the time

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period seen below, there is no statistically significant change in death rates and the rate of serious
injuries have a statistically significant downward trend as per the Jonckheere Terpstra test (p<.0001).
0.6
Death (by report date)

0.5

Serious Injury (by report date)

Death (by event date)

0.4

Serious Injury (by event date)

0.3

0.2

0.1

0
2011

2012

2013

2014

Figure 11: Trends of Serious Injury and Death MDR reports based on number of da Vinci procedures
completed from 2011-2014 based on report date or event date

The Serious Injury and Death MDRs data can also be assessed by procedure type (when available) to
look for any potential trends. The data presented in Figure 12 below show general alignment between
the percentage of procedures completed in 2014 in a given surgical specialty and the percentage of
MDRs filed in 2014 for that same specialty. The slightly higher rate of MDRs in the cardiac category is
not unexpected given that patient population.

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2014 MDRs by Procedure Category

ISI-FDA MEETING April 24, 2015

2014 Procedures Completed by Category

Figure 12: 2014 Death and Serious Injury MDRs by Procedure Category as Compared to all 2014
Completed Procedures by Category

In conclusion, the overall number of individual Serious Injury and Death MDRs has increased from 20112014 due to the absolute volume of da Vinci assisted surgical procedures being performed; however,
the rate is unchanged (death) or improving (serious injury). Also, the overwhelming driving force for the
dramatic increase in 2013 was related to aggressive advertising campaigns by plaintiff attorneys. That
said, even with the legal claims included, there is a statistically significant decrease in the rate of serious
injuries over the last 4 years when assessed by event date. Also, ISI believes that MDR data are best
analyzed as rates by occurrence date and not report date. Other unique factors to ISI (discussed above)
also greatly impact the type and number of reports filed by ISI. As there is likely a higher likelihood of
common surgical complications being reported to ISI versus laparoscopic or open surgery device
manufacturers, MDR data is unlikely an ideal means of comparing adverse event rates among da Vinci
surgery, laparoscopic surgery and open surgery. Finally, due to the limitations and factors influencing
complaint and MDR reporting, ISI believes that well designed clinical studies are the best source of valid
scientific data to robustly evalute device safety and effectiveness and to compare safety and
effectiveness between surgical approaches.

V.

ISIs Complaint Investigation Process

The Postmarket Surveillance department at ISI reviews, assesses, and investigates each complaint
individually within 24 hours of receipt. Information is gathered from all available sources for each case
to assist in determining the cause of the event. For Serious Injury and Death reports, information from
previous requests for additional information (AIs) from the FDA are always considered and addressed in
the MDR report to the extent the information is obtained during the investigation. In addition, all
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Serious Injury and Death reports are investigated by a medical professional and reviewed by an active da
Vinci surgeon.
Unfortunately, ISI encounters limitations outside of its control during the complaint investigation
process that may limit the amount of and type of information available about an event or patient. For
example, cases that are under active litigation may not be able to be discussed with the surgeon,
hospital, or other medical staff at the facility. In these cases, ISI typically has only partial information
provided by the attorney about a case. Even when a surgical complication is not yet the subject of
litigation, hospitals may fear litigation and refuse to release information or the device to ISI for analysis.
In these types of situations, due to the MDR timeline to report, the MDR may be submitted with very
little information and perhaps without a causal or contributory relationship to the device having been
established. Supplemental MDR reports are submitted whenever any additional information is
collected.
ISIs investigation process for these events includes reviewing all information available internally and
externally, including the following:
Internal Data
System logs
Contacting all ISI representatives
involved with the account
Review of previous complaints
Data trends
Failure analysis information
Field support to gather information

External Data
Contacting facility
personnel involved in
event

ISI strives to provide robust, thorough, and timely complaint investigations to facilitate an understanding
and analysis of all reported events. When reporting MDRs, ISI considers the information typically asked
for by FDA in its AI requests and provides that information if such is available. Below is a list of
information that ISI always attempts to include in its MDR reports. If the MDR report does not include
this information, then that is because the information is not available to ISI.
Standard Investigation for Adverse Events
Attending Medical Professionals opinion of event
Patients operative / autopsy report(s)
Patients current and pre-existing condition(s)
Status on the return of suspect device (if applicable)
Internal ISI medical review and opinion of event
da Vinci System Log review
Multiple follow-ups for data collection

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System Logs
As noted above, da Vinci System logs are reviewed as part of the complaint review process. System logs
are an additional source of information for the da Vinci System that is above and beyond what other
hand held device manufacturers have at their disposal. Due to the software and hardware of the da
Vinci System, some data related to system use can be collected and stored. These data are referred to
as system logs and include overall system status and error codes, the specific instruments used in each
procedure and pre-determined technical data. These data are stored on the System and transmitted
directly back to ISI, for sites that have a direct connection. Otherwise, the System logs are collected by
the field service personal at the next service visit and transmitted back to ISI at that time, which is
sometimes outside of the initial 30-day reporting window. System logs are commonly reviewed during
complaint investigations to correlate the specified device to the complaint (if applicable) or to
determine if any system information, data or error codes could be related to the specified complaint.
While system logs can be an advantageous tool in complaint investigation, they do have limitations. The
system logs are not immediately accessible for all systems, the logs do not detect every reportable issue,
and there are capacity limitations to how much information the logs can retain. The utility of system
logs will continue to grow and evolve, but in the meantime, system logs will remain only one piece to
our comprehensive complaint investigations.

VI.

Conclusion and Future Collaboration

Since its introduction, the da Vinci System has been used safely and effectively in over 2.5 million
procedures worldwide to offer minimally invasive surgery to a broader population of patients and to
improve the experience of minimally invasive surgery for patients and surgeons. The da Vinci System is
now a common part of many surgical practices in the United States, including urologic and gynecologic
surgery. ISI continually monitors the postmarket performance of da Vinci technology through the review
of published clinical literature in addition to monitoring of its MDR data. The clinical evidence base
studying da Vinci use is extremely large and growing rapidly. The largest studies of da Vinci use show
that it provides significant improvements in safety and effectiveness when the comparator is open
surgery, and also shows benefits when compared with laparoscopy. Further analyses show that there
are lower readmission rates for da Vinci assisted surgery than laparoscopic or open and that the
complication rates for learning surgeons are lower than the experienced surgeons using the alternative
surgical methods being displaced. In the analysis of adverse events, it is shown that overall adverse
event rates are both low and stable or improving over a long period despite the increased use of plaintiff
attorney internet, cable and other advertising.
As an organization, ISI is committed to innovation and continuous improvement in both our products
and our processes to improve surgery. Furthermore, we are committed to maintaining a productive and
collaborative relationship with the FDA and wish to support FDAs postmarket surveillance efforts. ISI
believes that MDR data are best analyzed by occurrence date and with denominator information. ISI
also believes that assessment of safety in the postmarket setting should include consideration of data
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ISI-FDA MEETING April 24, 2015

from clinical trials. We look forward to our April 24, 2015 meeting with FDA where we can hopefully
discuss how best to get this important information to FDA to support FDAs postmarket surveillance
efforts with regard to the da Vinci Surgical System.

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