ZILVER 635 SELF-EXPANDING BILIARY STENT
Report
- Report Number
- 3001845648-2022-00505
- Event Type
- Malfunction
- Date Received
- August 9, 2022
- Date of Event
- June 10, 2022
- Report Date
- September 12, 2022
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FGE
- UDI-DI
- 10827002372716
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA/510(K) # K182980. THE INVESTIGATION IS IN PROGRESS AND A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.
PMA/510(K) # K182980. ADDITIONAL INFORMATION RECEIVED ON 12-SEP-2022 FROM THE CUSTOMER "IT IS NOT A PC BUT A FAILURE FROM THE DOCTOR ABOUT THE SIZE." IT WAS ALSO CONFIRMED ON 13-SEP-2022 ¿ THE STENT WAS NOT USED - THE DOCTOR OPENED THE BOX BY MISTAKE¿. CANCELLATION REPORT BEING SUBMITTED. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿.
FAILURE TO PLACE.
ADDITIONAL INFORMATION RECEIVED ON 12-SEP-2022 FROM THE CUSTOMER "IT IS NOT A PC BUT A FAILURE FROM THE DOCTOR ABOUT THE SIZE." IT WAS ALSO CONFIRMED ON (B)(6) 2022 ¿ THE STENT WAS NOT USED - THE DOCTOR OPENED THE BOX BY MISTAKE¿. CANCELLATION REPORT BEING SUBMITTED. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED AS OCCURRING. THE EVENT DOES NOT MEET THE CRITERIA OF AN FDA ¿SERIOUS INJURY¿ REPORT OR ¿MALFUNCTION¿ REPORT AS PER FDA GUIDELINES ¿MEDICAL DEVICE REPORTING FOR MANUFACTURERS (2016)¿.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1988111 | ZILVER 635 SELF-EXPANDING BILIARY STENT | FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL | FGE | COOK IRELAND LTD | C1893068 | 10827002372716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |