PRODUCT RISK ASSESSMENT

Product family: Product variants (items) covered by this assessment:

Stone Extractor Dormia See detail enclosed

Date of assessment/review: 09/2016

Rev.: 10
Document No.: CRIQ202RMA (VV-0047637)

Participants
Na Initials Department Position Risk assessment role
me
Jean-Ann Carminade FRJAC R&D Risk Management Specialist Risk Management
Specialist/Responsible
Pascale Holliday- FRPHO Clinical Clinical Scientist Medical Expert
Bonnard
Stphane Bouch FRSBU RA Regulatory Affairs Manager RA

Sihem Darraji FRSDR RA Head of Regulatory Affairs RA

Frederic Marie FRFMR R&D R&D Director R&D

Approvers
Documented in Document Management System
Product variants (items) covered by this assessment:

Extractible New
REF Detail Ch Wires IFU
basket products

Titane-Nickel (Ti-Ni) Dormia

EXT224 DORMIA Stone extractor N-Stone 4 Ch No Nitinol - SH2138

EXT424 DORMIA Stone extractor N-Stone 3 Ch No Nitinol - SH2138

EXT624 DORMIA Stone extractor N-Stone 2.5 Ch No Nitinol - SH2138

EXN434 DORMIA Stone extractor NoTip 3 Ch No Nitinol 1119002000 SH2138

EXN734 DORMIA Stone extractor NoTip 2.2 Ch No Nitinol 1119002000 SH2167

EXN934 DORMIA Stone extractor NoTip 1.5 Ch No Nitinol 1119002000 SH2167

 IDENTIFICATION OF SAFETY RELATED MEDICAL DEVICE CHARACTERISTICS

No. Questions Answers

The stone extractors are used for extraction/removal of urinary

What is the intended use and how is the
tract calculi (stones) for all codes and biliary calculi for DOV5
medical device to be used?
and DOR5.
Treatment or alleviation?
1 - Used for treatment of stone extraction
Compensation for injury or handicap?
- Not for compensation for injury or handicap
Replacement or modification of anatomy?
- Not for replacement or modification of anatomy
Is the medical device intended to be
2 No
implanted?
Is the medical device intended to be in contact
3 Yes
with the patient or other persons?

Can be supplied with:

- Injector/re-introducer (if applicable)
- Tuohy-Borst Adapter (if applicable)

Can also be used with:

- Endoscope (Uteroscope, cystoscope or choledoscope)
What materials and/or components are
- Syringe for injector/re-introducer (if applicable)
incorporated in the medical device or are
- Contrast liquid (if applicable)
used with, or are in contact with the device?
- Water
- Laser (if applicable)
4 - Connectors or stopcock

Refer to the 'Product description and composition' document

for more details if available

Is energy delivered to and/or extracted from

5 No
the patient?
Yes, urinary tract or biliary stones are extracted.
Are substances delivered to and/or extracted
6 Contrast liquid can be injected, depending on the Dormia
from the patient?
reference.
Is the medical device supplied sterile or
7 intended to be sterilized by the user or are Supplied sterile (Single use)
other microbiological controls applicable?

Is the medical device intended to be routinely No single use. Dormia can be re-inserted several times, but
8
cleaned and disinfected by the user? only during the same procedure.

Is the medical device intended for use in

Radioscopic control
9 conjunction with medicines or other medical
Ultrasound or laser stone destruction
technologies?
Are there unwanted outputs of energy or
10 No
substances?
Is the medical device susceptible (sensible) to No (standard medical device storage: store away from light in
11
environmental influences? a cool and dry place)
12 Does the medical device influence the No
environment?
Yes, can be delivered separately:
Are there essential consumables or - Endoscope (Uteroscope, cystoscope or choledoscope)
13 accessories associated with the medical - Syringe for injector/re-introducer (if applicable)
device? - Ultrasound or laser stone destruction devices (if applicable)
- Connectors or stopcock
Is maintenance and/or calibration necessary
14 No
on the medical device?
15 Does the medical device contain software? No
16 Does the medical device have restricted shelf- Yes
life?
Are there any delayed and/or long term
17 No known effects
effects?
To what mechanical forces will the medical
18 Insertion and withdrawal forces
device be subjected?
What determines the lifetime of the medical
19 Material of the sheath (+ sterile barrier)
device?
20 Is the medical device intended for single use Yes
Is safe decommissioning or disposal of the
21 No - Discard after use (normal hospital waste)
medical device necessary?
Does installation or use of the medical device
22 Yes, trained specialist i.e. Urologist, Gastroenterologist
require special training or special skills?
How will information for safe use be
23 Labelling / IFU
provided?
Has usability been evaluated as part of the
24 Yes, refer to relevant 'Usability Assessment' document
design phase?
Will new manufacturing processes need to be Yes, Transfer of technology from Epflex to Porgs :
25
established or introduced? manufacturing for SS4148 EXN734 No tip CH 2.2
Is the successful application of the medical
26 device critically dependent on human factors No (if used by trained physicians)
such as the user interface?
27 Can the user interface design features Handle - wrong handling of the slider
contribute to user error?
Is the medical device used in an environment
28 No - Device used in operating room
where distractions are commonplace?
Yes, for some references, Luer injector/re-introducer, for
Does the medical device have connecting
29 injection of contrast medium and re- sertion of the metallic
parts or accessories?
part in the sheath
Does the medical device have a control
30 No
interface?
31 Does the medical device display information? No
32 Is the medical device controlled by a menu? No
Will the medical device be used by persons
33 No
with special needs
34 Does the medical device use an alarm system? No
Does the medical device incorporate, as an Yes : Tallow derivatives manufactured by rigorous process
35 integral part a human blood derivative or according to EN ISO 22442-1 for DOR54x, DOR555, Dor7xx,
tissues of animal origin? DOV5xx.
Yes DOR5 and DOV5 Contain DIMP Phthalates (Not
classified as dangerous):
Does the medical device contain phthalates
Protective cap that is not in contact with body fluids so not
which are classified as carcinogenic,
36 intended to administer and/or remove medicines, body liquids
mutagenic or toxic to reproduction?
or other substances to or from the body, or devices intended for
transport and storage of such body fluids or substances
 Defining situations of use, hazards and hazardous situations

After identifying the characteristics related to safety it is possible to define the situations of use. The situations of use can
be defined for an individual product or product family. The situations of use describe the scenario and context in which
the device is applied.
The characteristics related to safety combined with the defined situations of use form the basis of deriving hazards and
hazardous situations. The situations can both reflect the intended use and reasonably foreseeable misuse. Many of the
hazards the user can experience originate from various sources/causes and can be introduced throughout the product life
cycle.
The hazard type refers to the hazard types defined in the the FMECA sheet (biological, chemical etc.)

Situations of use:
Product variant: Specific Hazards for Dormia Stainless Steel
Describe situation of Describe situation of use Describe situation of use # Describe situation of use # 4: Describe situation of use #
use # 1: # 2: 3: 5:

Preliminary Preparation and Injection of contrast Use of device: Removal and reassembling
medical Insertion of device: medium: - Dormia shall be easily handled of device:
precautions - Dormia shall be - Dormia injector/re- with one hand to open the basket - Dormia shall be
compatible with introducer shall be easily #1 withdrawn from the
endoscope #1 connected to syringe or to - Dormia basket shall open patient #1
- Dormia shall slide sheath #1 #2 correctly #2 #3 - for filiform tip: Dormia
easily to position the - Dormia shall allow contrast #4 shall keep the access path
basket over the stone #2 liquid injection - Dormia basket shall dilate to the ureter #2
- Dormia shall be visible #3 ureter or choledoc canal when - Dormia shall be dismantled
(ORX or marking) - Metallic part shall be re- opening #5 in case of stone not going
#3 #4 introduced in the sheath - - Dormia basket shall trap stones through the endoscope #3
- Dormia shall not release See Situation of use #5 - by closing - for DOR7: Dormia shall
PTFE particles in patient Situation #6 be cuttable with tools #3
body #5 #4 - Dormia shall withstand - Dormia shall be
several cycle of basket reassembled outside the
opening/closing #7 #8 #9 #10 patient #4
- Dormia shall not be used
together with a fragmenting
device #11
- Dormia shall be atraumatic #12

Hazardous situation # Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1:
1:
Off label use of product Dormia is not Dormia injector/re- Dormia handle cannot be Dormia withdrawal is
compatible with introducer cannot be manipulated with one hand (or impossible
endoscope connected to the sheath with difficulty) (or with difficulty)

Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Physical Physical Physical Use of product

Hazardous stituation # Hazardous stituation # 2: Hazardous stituation # 2: Hazardous stituation # 2: Hazardous stituation # 2:
2:
Contrast medium side Dormia cannot pass the Syringe cannot be connected Basket cannot be opened (or with Dormia filiform tip
effect calculus to the Dormia injector/re- difficulty) cannot maintain the
introducer ureteral path

Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Use of product Physical Physical Production
Hazardous stituation # Hazardous stituation # 3: Hazardous stituation # 3: Hazardous stituation # 3: Hazardous stituation # 3:
3:
The patient is allergic Dormia radio opacity Contrast medium cannot Opened basket comes only Dormia cannot be dismantled
to device materials (ORX) is out of be injected partially out of the sheath
specifications
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Chemical Physical Physical Physical
Hazardous situation # Hazardous situation # 4: Hazardous situation # 4: Hazardous situation # 4:
4:
Patient cannot endure Dormia marking is Opened basket comes out of the Dormia cannot be
stone extraction out of specifications sheath too much reassembled
procedure

Hazard type: Hazard type: Hazard type: Hazard type:

Use of product Physical Physical Use of product

Hazardous situation # Hazardous situation # 5: Hazardous situation # 5:
5:
Product cannot be used PTFE particles Basket does not dilate the ureter /
for biliary extraction introduced in ureter choledoc canal or insufficiently

Hazard type: Hazard type: Hazard type:

Use of product Use of product Physical
Hazardous situation # Hazardous situation # 6:
6:
Dormia causing Dormia basket cannot trap the
iatrogenic burns stones (or with difficulty)
Hazard type: Hazard type:
Use of product Physical

Hazardous situation # 7:
Basket cannot be opened/closed
several times - Sheath and handle
are getting disassembled

Hazard type:
Physical
Hazardous situation # 8:
Basket cannot be opened/closed
several times - Metallic part
breaks
Hazard type:
Physical
Hazardous situation # 9:
Basket cannot be opened/closed
several times - Sheath damaged
or broken
Hazard type:
Production
Hazardous situation # 10:
Basket cannot be opened/closed
several times - Handle anomaly

Hazard type:
Production
Hazardous situation # 11:
Dormia is damaged by stone
fragmenting device
Hazard type:
Use of product
Hazardous situation # 12:
Dormia distal tip is traumatic
Hazard type:
Use of product
 Defining situations of use, hazards and hazardous situations

After identifying the characteristics related to safety it is possible to define the situations of use. The situations of use can
be defined for an individual product or product family. The situations of use describes the scenario and context in which
the device is applied.
The characteristics related to safety combined with the defined situations of use form the basis of deriving hazards and
haza rdous situations. The situations can both reflect the intended use and reasonably foreseeable misuse. Many of the
hazards the user can experience originates from various sources/causes and can be introduced throughout the product life
cycle.
The hazard type refers to the hazard types defined in the the FMECA sheet (biological, chemical etc.)

Situations of use:
Product variant: Specific Hazards for Dormia Titane-Nickel

Describe situation of use Describe situation of use # 2:
# 1:
Preliminary medical Preparation and insertion of
precautions device:
- Tuohy-Borst Adapter shall be
easily connected to endoscope
#1
- Dormia shall be compatible with
Tuohy-Borst
Adapter and endoscope #2 #3
- Tuohy-Borst Adapter shall be
waterproof #4
- Dormia shall slide easily to
position the basket over the stone
#5
- Dormia shall be visible (ORX)
#6
- Dormia shall not release PTFE
particles in patient body #7
Describe situation of use # 3:
Use of device:
- Dormia shall be easily handled with
one hand to open the basket #1
- Dormia basket shall open correctly #2
#3 #4
- Dormia basket shall dilate ureter when
opening #5
- Dormia basket shall trap stones by
closing #6
- Dormia shall withstand
several cycle of basket
opening/closing #7 #8 #9 #10
- Dormia shall not be used together
with a fragmenting device #11
- Dormia shall be atraumatic #12
Describe situation of use # 4:
Removal and reassembling of
device:
- Dormia shall be withdrawn from
the patient #1
- Dormia shall be dismantled in
case of stone not going through
the endoscope #2
- Dormia shall be reassembled
outside the patient
#3

Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1:

Off label use of product Tuohy-Borst adapter cannot be Dormia handle cannot be manipulated Dormia withdrawal is impossible
connected to endoscope (or with with one hand (or with difficulty) (or with difficulty)
difficulty)
Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Physical Physical Use of product
Hazardous stituation # 2: Hazardous stituation # 2: Hazardous stituation # 2: Hazardous stituation # 2:

The patient is Dormia cannot go through Basket cannot be opened (or with Dormia cannot be dismantled
allergic to device Tuohy-Borst adapter difficulty)
materials
Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Physical Physical Physical

Hazardous stituation # 3: Hazardous stituation # 3: Hazardous stituation # 3: Hazardous stituation # 3:

Patient cannot endure Dormia is not compatible with Opened basket comes only partially Dormia cannot be reassembled
stone extraction procedure endoscope out of the sheath
Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Physical Physical Use of product
Hazardous stituation # 4: Hazardous stituation # 4: Hazardous stituation # 4:
Dormia causing iatrogenic Tuohy-Borst Adapter is not Opened basket comes out of the
burns waterproof sheath too much
Hazard type: Hazard type: Hazard type:
Use of product Physical Physical
Hazardous situation # 5: Hazardous situation # 5:
Dormia cannot pass the Basket does not open with the right
caculus in the ureter shape
Hazard type: Hazard type:
Use of product Physical
Hazardous situation # 6: Hazardous situation # 6:
Dormia radio opacity Dormia basket cannot catch the stones
(ORX) is out of (or with difficulty)
specifications
Hazard type: Hazard type:
Physical Physical

Hazardous situation # 7: Hazardous situation # 7:

PTFE particles introduced in Basket cannot be opened/closed several
ureter times - Sheath and handle are getting
disassembled
Hazard type: Hazard type:
Use of product Physical
Hazardous situation # 8:
Basket cannot be opened/closed several
times - Metallic part breaks
Hazard type:
Physical
Hazardous situation # 9:
Basket cannot be opened/closed several
times - Sheath damaged or broken
Hazard type:
Production
Hazardous situation # 10:
Basket cannot be opened/closed several
times - Handle anomaly
Hazard type:
Production
Hazardous situation # 11:
Dormia is damaged by stone
fragmenting device
Hazard type:
Use of product
Hazardous situation # 12:
Dormia distal tip is traumatic
Hazard type:
Use of product
 Defining situations of use, hazards and hazardous situations

After identifying the characteristics related to safety it is possible to define the situations of use. The situations of use can be defined for an individual product or
product family. The situations of use describes the scenario and context in which t he device is applied.
The characteristics related to safety combined with the defined situations of use form the basis of deriving hazards and haza rdous situations. The situations can both
reflect the intended use and reasonably forseeable misuse. Many of the hazards the user can experience originates from various sources/causes and can be introduced
throughout the product life cycle.
The hazard type refers to the hazard types defined in the the FMECA sheet (biological, chemical etc.)
Situations of use:
Product variant: Generic Hazards for Stone Extractor Dormia
Describe situation of Describe situation of Describe situation of use # Describe situation of Describe situation of Describe situation of Describe situation of use #
use # 1: Primary use # 2: Labelling 3: Shelf life use # 4: use # 5: Product use # 6: Re- 7: Disposal
packaging Biocompatibility Sterilisation (EtO) sterilization

Opening of primary Incorrect handling of Shelf-life, storage (end user, Use of biocompatible Use of sterile product Re-packaging of Disposal
packaging and product Post-market sales reps) and distribution device and clean product product before - Hospital
removal of product product identification of product - Before use all materials sterilization - Discontinuation of product
from packaging not possible - Maintain sterile barrier shall be biocompatible - Re-work by Coloplast
Primary packaging - Maintain product (biological / chemical) - Re-use by customer
shall: performance - All materials shall be
- Be easy to open stable for product life in
- Facilitate the removal terms of biocompatibility
of the product (mechanical / biological)
- Maintain clean and
sterile product
- Maintain sterile
procedure, when
required
Hazardous situation # Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1: Hazardous situation # 1:
1:
Difficult to open peel Correct labelling & Product performance not Product not Product cannot be Product re-sterilized too Product discarded as "normal"
pouch/tray product - but user mistake according to specification biocompatible with the sterilized many times waste and not as "hospital"
- dimension problem (i.e. : tissues / mucosa / body (by Coloplast) waste
4Ch instead of 2.5Ch) fluids

Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Use of product Physical Biological Production Production Disposal
Hazardous situation # Hazardous situation # 2: Hazardous situation # 2: Hazardous situation # 2: Hazardous situation # 2: Hazardous situation # 2: Hazardous situation # 2:
2:
Impossible to open peel Inconsistent labelling / Use of unsterile product Product is a vector of Product not sterilized Reuse of a single use Unauthorized use
pouch/tray labelling does not match pathogenic agents according to product - Marketing discontinue
product - dimension specification (EtO) product due to unsafe
problem (i.e. : 4Ch instead performance
of 2.5Ch) or quantity of - Recall of product
products in the packaging

Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Production Distribution Chemical Production Use of product Use of product
Hazardous situation # Hazardous situation # 3: Hazardous situation # 3: Hazardous situation # 3: Hazardous situation # 3: Hazardous situation # 3:
3:
Packaging not opened as Absence or wrong place of Sterility compromised during Degradation of product Products not subjected to Contamination of product
intended IFU / shelf life from exposure to body sterilization cycle during re- work (by
labels or printed environment Coloplast)
information

Hazard type: Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Production Storage Chemical Production Production
Hazardous situation # Hazardous situation # 4: Hazardous situation # 4: Hazardous situation # 4: Hazardous situation # 4:
4:
Product / tray falls out Wrong labelling (old Loss of product performance Degradation of product Excessive bio-burden
version, text mistakes) (due to exposure to from exposure to before sterilization
temperature and humidity accessory product (oil,
outside recommended gels )
storage/distribution
conditions)
Hazard type: Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Use of product Environmental Chemical Biological
Hazardous situation # Hazardous situation # 5: Hazardous situation # 5: Hazardous situation # 5:
5:
Product / tray difficult or Missing required symbols Loss of product performance Inadequate EtO degassing
impossible to access (single (due to exposure to UV light
after opening use, sterile,) outside recommended
storage/distribution
conditions)
Hazard type: Hazard type: Hazard type: Hazard type:
Use of product Production Environmental Chemical
Hazardous situation # Hazardous situation # 6: Hazardous situation # 6: Hazardous situation # 6:
6:
Lack of barrier Wrong or inconsistent Discolouration (due to Unclean product
properties for primary required symbols (single exposure to UV light outside
packaging use, sterile,...) recommended
storage/distribution
conditions)
Hazard type: Hazard type: Hazard type: Hazard type:
Physical Production Environmental Physical
Hazardous situation # 7:

Not readable labelling

Hazard type:
Production
Hazardous situation # 8:

Labelling not
understandable
Hazard type:
Use of product
Hazardous situation # 9:

Inconsistent shelf-life:
- labelling consistent but
differs from the real
product shelf-life
Hazard type:
Production
Hazardous situation #
10:
Inconsistent shelf-
life:
-labelling inconsistent
(shelf-life on pouch label
differs from shelf-life on
box)
Hazard type:
Production
Hazardous situation #
11:
No traceability (for recall
or complaint)
Hazard type:
Distribution
1. Scope
The purpose of this hazard guidance paper is to define what a hazard is, generically, and define the specific types of
hazards that are predefined in the corporate template for product risk assessment.

2. Hazards
What is a hazard? A hazard is a potential source of harm. Literature [The Royal Society, 2002] defines three types
of hazards
Natural hazards (volcanoes, virus, bacteria etc.)
Technological hazards (nuclear plants, trains, medical devices etc.)
Social hazards (war, arson, terror etc.)

When talking medical devices the most frequent are natural hazards (bacteria, chemicals, virus etc.) and
technological hazards (the application of the device and its features). A hazard has no relevance (the risk is low) if
you are not in a situation where the hazard can inflict harm on you.
A hazard can appear in many shapes and forms. Normally we regard a hazard as an object or a part of an object
that can harm us directly physically, e.g. a sharp edge on a catheter.

But hazards can also appear more abstract, e.g. a leaky urine bag that can induce a psychological reaction (harm)
on the patei nt. Furthermore software in a pulse sensor, applied on a critically ill patient, that fails and thereby
prevents an alarm form alarming a caregiver when the patients pulse drops. Inthis context the alarm can be defined
as the hazard because its absence can result in serious harm to the patient.

The situation where you are at risk (because the hazard can inflict harm on you) is a hazardous situation.
With respect to medical devices the hazardous situations are often in conjunction with the use of the device. The
use of thedevice is based on the intended use defined. It is important always to bare this in mind.

3. Specific types of hazards

The headings (below) are only meant as an aid to initiate thoughts.
The objective is to identify as many hazards associated with the device as possible. This implies, that the main
purpose of the headings is to generate identification of hazards not necessarily to structure them in a certain manner
(under a correct heading).

3.1. Biological hazards

Biological hazards are biological components; bacteria, virus, bio-burden etc. on devices, which can induce
infection, disease e tc. on the device user. Biological hazards can be applied throughout product realization.
Because of this it is mentioned several times in the sections below.
 It must be noted that this definition differs from the definition of a biological hazard given in DS/EN ISO
10993-1 where a biological hazard is defined as the harm on a living organism. The author of this paper
(DKPAJ, Corporate Q&E) disagrees with the ISO definition.

3.2. Chemical hazards

Unwanted leachable substances in raw materials/devices; residuals, contaminants, process chemicals (can
induce biological harm).
Unwanted substances in production processes e.g. EtO, due to sterilization (can induce biological harm).
Product degradation (induces a biological harm).

Chemical hazards can often induce biological harm on the user.

In this context, as mentioned in section 3.1, it must be emphasized that DS/EN ISO 10993-1 defines biological
harms as biologica l hazards. In order to describe which biological harms chemical hazards can induce
examples are outlined below:
Cytotoxicity (can induce skin damage)
Sensitization (can induce allergy)
Irritation or intracutaneous reactivity (can induce eczema)
Systemic toxicity (acute) (can induce damage to living biological system/internal organs)
Sub acute and sub chronic toxicity (do.)
Chronic toxicity (do.)

A more profound definition of these effects is given in DS/EN ISO 10993-1, Table 1. This list is non
exhaustive.

3.3. Physical hazards

Defects (hardware, mechanical or software) in device (can induce or results in harm). E.g. a software
defect prevents an essential alarm from working thus resulting in severe injury to user(s).
Leaky bag (ostomy or urine) (can induce faeces on patient and social embarrassment).
Edges or other dominate features or components/materials on device (can induce harm on user).
Too little fluid handling capacity (can induces wound substances to user and user environment)
Inadequate or too much adhesive effect (can induce that products fall off, rips off skin resulting in non
conformance e.g.bad treatment, infection etc.)

3.4. Environmental hazards

Conditions in the users environment that affects the device or the user e.g. contaminated toilets,
electromagnetic radiation, noise etc.
Features in the device (electronics, radio signals, chemical substances etc.) that can affect the users
environment and thereby undeliberately result in harm of persons.
 Used devices can contain human liquids (blood mucus etc.) that, undeliberately can induce harm on
persons.
Light/UV exposure that damages the device.

3.5. Procurement hazards

Contaminated (chemicals, bio-burden or physical objects) raw material (can induce biological harm to
patients)
Defect raw materials (can induce physical harm on user).

3.6. Production hazards

Too much or too little silver/Ibuprofen applied in foam (can induce non conformance)
Contamination of device components (can induce biological harm or physical harm on user(s)).
Contaminated (chemicals, bio-burden or physical objects) raw material (can induce biological harm to
patients)
Defect raw materials (can induce physical harm on user).
Silver, Ibuprofen in Biatain foam (where its not supposed to be) (can induce physical effects on user).
Insufficient sterilization.
Damage to primary packaging.
Pinholes in foil.
No lock holes in catheter.
Not rounded catheter
Sharp tip on catheter

The causes to many of these hazards (if the risk the hazards pose is unacceptable) are identified in the process
risk assessment and often mitigated by process validation and clean room validation.

3.7. Distribution hazards

Physical defects applied to devices primary or secondary packaging during handling.

3.8. Storage hazards

Physical defects applied to devices primary or secondary packaging during storage.

3.9. Hazard associated with the use of the product

Use on dry wound
Use on patient with known allergy towards dressing component
Too small dressing used
Up-side-down application
Misplacement of dressing
Patient eating the device components
 Use of non-sterile device (harm = local infection), see section 3.1, 3.3 and 3.4.
Unintended use of device or reasonably foreseeable misuse of the device.
The device gets into hands of children (not intended)

3.10. Disposal hazard

The device (product/packaging) poses a risk to its environment because it is not properly discarded. Device
will be able toinduce bacteria/virus on other devices and patients/operators.
See section 3.4

4. Conclusion
Hazards are the potential source of harm. They can appear concrete or mere abstract. The non-exhaustive list over
specific hazards is only intended as a basis for identifying hazards in association with product risk assessment (some of
which affect the process risk assessment). The objective with the list is not to place a hazard under a correct heading,
but to generate the identification of as many hazards associated with the device as possible.
SEVERI RATING Definition
TY Urology & Continence Care
GROUP
- Death
5
- Irreversible damage to Central Nervous System or Cardio Vascular System
- Untreatable infection/virus (short term life expectance)

- Irreversible damage to body systems/organs other than Central Nervous System or

4 Cardio Vascular System. E.g. urethra, bladder, ureter, kidney, gallbladder, breast, other
organs.
SAFETY SEVERITY

Reversible damage to body systems/organs:

- With surgery.
- With surgical re-intervention.
- With surgery extended extremely
3
- With temporary functional replacement.
- With medical intervention.
- Ex-planation of an implant
- Cystoscopy or other new surgery to retrieve catheter/device part
- Transrectal or suprapubic piercing to deflate balloon catheter
- Percutaneous Nephrostomy to drain the kidney due to ureteral stent/pusher failure.
- Suprapubic drainage due to urethral catheter failure.
- Open surgery instead of coelioscopy or endourologic procedure due to device failure

- Prolonged procedure (surgery)

CONFORMANCE

- Replacement of device during the surgery

- Minor product characteristics mistakes
SEVERITY

2 - Inconvenience for the health care professional and for the patient/end-user
NON-

- No inconvenience for the patient/end-user

- Minor Inconvenience only for the physician
- Visual perception
- Product missing
1
- Visual defects
- No impact on health or intended use
 SET- UP OF PROBABILITY

In the table the probability of harm is determined. This sheet contains two tables - one for low
volume surgical devices and one for the rest of the device portfolio. The probability table for low
volume devices is used for Long-Term Implantable Surgical Devices and Disposable Surgical
Urology devices with projected annual sales <30,000 units.

This includes the following Product Families for Disposable Surgical Urology devices: See
DOCAQ12003 List of Low volume DHFs according to SBA06023

Probability of occurrence of harm

Qualitative Part Quantitative Part
Link to Procent
F-value Qualitative Range (ppm) link to Ppk failure or
defective
rate
5 Frequent 10.001-100.000 1.7 3.6%
4 Probable 1001-10.000 1.6 0.27%
3 Occasional 101-1000 1.4 0.032%
2 Remote 11-100 1.2 0.0027%
1 Improbable 1-10 1 0.00016%

Probability Low Volume Devices

Qualitative Part Quantitative Part
Link to Procent
F-value Qualitative Range (ppm) link to Ppk failure or
defective
5 Frequent > 30000 1.3 rate 5.1%
4 Probable 15001 - 30000 3
1 2.4%

3 Occasional 5001 - 15000 0.8 1.1%

2 Remote 1001 - 5000 5
0.7 0.27%
1 Improbable 1- 5
0.6 0.0066%
1000 5
 SET- UP OF DETECTABILITY
The user's ability to detect a product defect before or
during use, but before harm is inflicted to the user. RANKING
Frequent 1
Lack of component
Large holes in primary package
Visual defect
Surgeon do not follow standard operating procedure/pre-treatment
Other
Probable 2
Lack of component
Lack of coating on catheter
Visual flaw in molded parts
Air bubbles in breast prosthesis
Visual defect
Sterile procedure in operating room not possible
Other
Occasional 3
Visual welding defect
Physician chooses wrong implant/device
Other
Remote 4
Partial coating of catheter
Lack of "eye" on catheter
Burr on the edge of "eye"
Lack of chamfer on catheter
Hole in baloon on catheter
Visual defect
Other
Improbable 5
Lacking or wrong sterilization
Lack of or insuficient adhesive ability
Pinholes in primary package or device
Incapable of absorbing
Too high or too low dose of active ingredient
Usage of wrong raw materiel
Invisible welding defect
Cross contamination
Implant malfunction (product performance error)
Other
 RISK ACCEPTABILITY CRITERIA

This matrix shows the criteria for risk acceptability. When the individual risks have been estimated the
evaluation is done by plotting the risk into this matrix. Every risk that falls into the red area is unacceptable
and must be controlled. This is done by reducing the "PxD" value in order to "push" the unacceptable risk into
the green area.

Severity
Probability x
1 2 3 4 5
Detectability

21 - 25

16 - 20 (Red)

11 - 15

6 - 10 (Green)

1-5

Approved by FRFMR Frederic Marie

Director R&D & RA
Management
22-Sep-2016 09:50:32 GMT+0000

Document Owner: FRJAC Jean Ann Caminade