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Home
Single Use Instruments
Menu Toggle
General Surgical Instruments
Gynacological Instruments
Single Use Dental Instruments
Single Use Surgical Forceps
Single Use Surgical Scissors
Electro Surgical Instruments
Menu Toggle
Artery Sealler
Bipolar Artery Sealler & Diathermy Connecting Cables
Gynaecology Instruments
Laryngoscope
Layproscopic Electrodes
Reuseable Bipolar Forceps
Reuseable Monpolar Forceps
Single Use Bipolar Forceps
Single Use Diathermy Electrodes
Services
Menu Toggle
ETO Commercial Sterilization
Post Market Surveillance
B&H Surgical Instrument
Post Market Surveillance
Form # FM10-09/03
Revision #: 03
Effective Date: 01st July, 2019
B & H Surgical Instrument - Post Market Surveillance
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Kindly select product type
Surgical
Electrosurgical
Date / Time
Customer Name / Hospital Name / Clinic Name:
Contact Person
Email
Address
Address Line 1
Address Line 2
Product Name
Category
Country Of Origin
Date / Time | Start Time
Date / Time | End Time
Kindly advise if B&H Surgical Instrument`s Products are being reshipped / being sold in the same origin are in different origins?
Yes
No
If yes please explain detail of country of origins
If you feel any problem with the packaging of B & H Surgial Instruments products?
Yes
No
If Yes please explain here
If you feel any kind of residual effect in B&H instrument`s Products packaging?
Yes
No
If Yes please explain here
If you feel any cleaning problem with the B&H instrument sterile packaging?
Yes
No
If Yes please explain here
If you feel any Cleaning problem with the B&H instrument`s products sterility?
Yes
No
If Yes please explain here
If B&H reusable instrument is autoclaved properly before use or reuse?
Yes
No
If Yes please explain here the temperature and number of autoclave cycles
If B&H reusable instrument is being used repeatedly on single / multiple patients / subjects?
Yes
No
If Yes please explain here the intervals and details of the patients/subjects likewise names, contact numbers, etc.
If the B & H Surgical instruments is being shipped with the relevant IFU (Instructions For Use)?
Yes
No
If the B & H Surgical Instrument is being used as per its intended use?
Yes
No
If No please explain here the issues
If the instrument is being used by the Technical expert / Surgeon / Physician / Specialist / Technician?
Yes
No
If yes please write here the name, qualification and contact number of Technical expert / Surgeon / Physician / Specialist
If the Technical Expert / Surgeon/ Physician/ Specialist was quite satisfied after using B & H Surgical Instruments?
Yes
No
If no please explain here the issues
If the B&H Instrument is being used by the End User?
Yes
No
If yes please write here the name, qualification and contact number of end user
If the end user is well trained to use the B&H Surgical instruments as per intended use? (Strictly advised to read the IFU)
Yes
No
If the IFU has been studied properly by the end user before using the instrument as per its intended use?
Yes
No
If the B&H single use / reusable instrument is being used on a single or multiple patients/subjects?
Yes
No
If Yes please explain here the intervals and details of the patients / subjects likewise name, contact numbers etc
If the B&H Surgical Instrument is being used in different user populations?
Yes
No
If yes please explain population size and performance
If B&H Surgical Instrument is being used individually or after fitting with other medical devices?
Yes
No
If yes please provide here the detail of those medical devices before and after use
If any kind of compatibility / fitting problem is identified with the B&H Surgical Instruments during intended use?
Yes
No
If yes please explain here
If any kind of worst event / Incident Claim / Trouble Shooting is recorded / identified during use of B&H Surgical Instruments?
Yes
No
If yes please explain here
If any kind of worst event / advisory notice is recorded / identified with the similar category instruments with the different brands?
Yes
No
If yes please explain here
If B&H Surgical Instruments product recall is recorded at your side?
Yes
No
If yes please provide here the detail of the items
If any kind of risk assessment is performed on the B&H Instrument or with the similar category instrument having different brands?
Yes
No
If yes please share the report with B&H at out email office@bhsi.com.pk
If you find any biocompatibility issue with B&H Surgical Instruments is recorded?
Yes
No
If yes please explain here
If you find any mechanical defect in B&H Surgical Instruments is recorded?
Yes
No
If yes please explain here
If you find any chemical / oxidation defect in B&H Surgical Instruments is recorded?
Yes
No
If yes please explain here
Kindly advise the specifications of Finger Switch / ESU Generator being used for the B&H electro surgical instrument / products (Bipolar & Monopolar)?
Yes
No
If yes please explain here
If any critical issue found regarding the performance and functionality of B&H Surgical Instruments needs to addressed in Risk Assessment?
Yes
No
If yes please explain here
If any principle of operation / mode of action / Issue recorded regarding B&H Surgical Instruments?
Yes
No
If yes please explain here
If any environmental effect identified on B&H Surgical Instruments?
Yes
No
If yes please explain here
If any performance effect recorded while performing sterilization other than ETO sterilization?
Yes
No
If yes please explain here
If any performance / functional effect recorded after expiry of B&H Surgical Instruments?
Yes
No
If yes please explain here
If any incident recorded due to the indication of use of B&H Surgical Instruments?
Yes
No
If yes please explain here
If any incident recorded due to the contradiction of use of B&H Surgical Instruments?
Yes
No
If yes please explain here
If any medicinal substance, Human Blood derivatives and phthalates from B&H Surgical Instruments?
Yes
No
If yes please explain here
Kindly advise if B&H surgical Instrument Products are being used after fitting with any source devices?
Yes
No
If yes please explain the specifications of the source devices
If any fitting issue is identified with the fitting of the source devices?
Yes
No
If yes please explain here
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