HEMOLOK TAKEAPART ML 5MM ENDO APPLIER
Report
- Report Number
- 3011137372-2023-00005
- Event Type
- Malfunction
- Date Received
- January 9, 2023
- Date of Event
- December 26, 2022
- Report Date
- December 26, 2022
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- GDO
- UDI-DI
- 24026704697841
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(4). THE INSTRUMENT WAS NOT SENT FOR EXAMINATION. WE COULD NOT PERFORM A FUNCTIONAL TEST TO REPRODUCE AND UNDERSTAND THE PROBLEM. THE INSTRUMENT W/ LOT O2 - 03 WAS SHIPPED TO TELEFLEX WITH INVOICE #2227150 OF 2022/03/15 ORIGINAL MANUFACTURING LOT IS 22143325. UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE AFFECTED LOT NUMBER, WE CAN CONFIRM THAT BOTH THE CORRECT MATERIAL AND CORRECT COMPONENTS HAD BEEN USED AND THAT THE INSTRUMENT MEETS THE PRODUCT SPECIFICATIONS. ALL PROCESS STEPS WERE FOUND TO HAVE BEEN PROPERLY DOCUMENTED. 100% FUNCTIONAL TEST AT FINAL INSPECTION FOUND GOOD. THE ROOT CAUSE COULD NOT BE DETERMINED AS PRODUCT WAS NOT RETURNED. NO FURTHER MEASURES WILL BE INITIATED BY K & W.
(B)(4). THE COMPLAINT HAS ALREADY BEEN ANSWERED WITH OUR OPERATION NUMBER 22300013 AS A COMPLAINT WITHOUT AN INSTRUMENT PRESENT. THE INSTRUMENT IS NOW AVAILABLE, AND WE HAVE PERFORMED SEVERAL CLIP CHECKS. ALL CLIPS COULD BE PICKED UP AND APPLIED WITHOUT ANY PROBLEMS. WE WERE UNABLE TO REPRODUCE THE ERROR DESCRIBED. THE FOLLOWING SHIPPING DETAILS WERE ESTABLISHED: THE INSTRUMENT W/ LOT O2 - 03 WAS SHIPPED TO TFX WITH INVOICE #2227150 OF 22/03/15. ORIGINAL MANUFACTURING LOT IS 22143325, HR REVIEW: UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE AFFECTED LOT NUMBER, WE CAN CONFIRM THAT BOTH THE CORRECT MATERIAL AND CORRECT COMPONENTS HAD BEEN USED AND THAT THE INSTRUMENT MEETS THE PRODUCT SPECIFICATIONS. ALL PROCESS STEPS WERE FOUND TO HAVE BEEN PROPERLY DOCUMENTED. 100% FUNCTIONAL TEST AT FINAL INSPECTION FOUND GOOD. THE INSTRUMENT IS WORKING PROPERLY AND IS NOT THE CAUSE OF THE ERROR. POSSIBLE CAUSES ARE USER ERRORS OR FAULTY CLIPS. NO FURTHER MEASURES WILL BE INITIATED BY K & W; THIS COMPLAINT IS BEING REJECTED BY US.
QN#(B)(4). THE COMPLAINT HAS ALREADY BEEN ANSWERED WITH OUR OPERATION NUMBER (B)(4) AS A COMPLAINT WITHOUT AN INSTRUMENT PRESENT. THE INSTRUMENT IS NOW AVAILABLE, AND WE HAVE PERFORMED SEVERAL CLIP CHECKS. ALL CLIPS COULD BE PICKED UP AND APPLIED WITHOUT ANY PROBLEMS. WE WERE UNABLE TO REPRODUCE THE ERROR DESCRIBED. UPON REVIEW OF THE DEVICE HISTORY RECORDS FOR THE AFFECTED LOT NUMBER, WE CAN CONFIRM THAT BOTH THE CORRECT MATERIAL AND CORRECT COMPONENTS HAD BEEN USED AND THAT THE INSTRUMENT MEETS THE PRODUCT SPECIFICATIONS. ALL PROCESS STEPS WERE FOUND TO HAVE BEEN PROPERLY DOCUMENTED WITH 100% FUNCTIONAL TEST AT FINAL INSPECTION FOUND GOOD. THE INSTRUMENT IS WORKING PROPERLY AND IS NOT THE CAUSE OF THE ERROR. POSSIBLE CAUSES ARE USER ERRORS OR FAULTY CLIPS. NO FURTHER MEASURES WILL BE INITIATED BY K & W.
(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.
IT WAS REPORTED THAT THE USER WAS UNABLE TO LOAD CLIPS INTO APPLIER BECAUSE CLIPS GOT BROKEN AT LOADING. THEREFORE, ANOTHER TAKE APART WAS USED INSTEAD, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO REPORTED INJURY.
IT WAS REPORTED THAT THE USER WAS UNABLE TO LOAD CLIPS INTO APPLIER BECAUSE CLIPS GOT BROKEN AT LOADING. THEREFORE, ANOTHER TAKEAPART WAS USED INSTEAD, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO REPORTED INJURY.
IT WAS REPORTED THAT THE USER WAS UNABLE TO LOAD CLIPS INTO APPLIER BECAUSE CLIPS GOT BROKEN AT LOADING. THEREFORE, ANOTHER TAKE APART WAS USED INSTEAD, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO REPORTED INJURY.
IT WAS REPORTED THAT THE USER WAS UNABLE TO LOAD CLIPS INTO APPLIER BECAUSE CLIPS GOT BROKEN AT LOADING. THEREFORE, ANOTHER TAKE APART WAS USED INSTEAD, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WAS NO REPORTED INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1723393 | HEMOLOK TAKEAPART ML 5MM ENDO APPLIER | APPLIER, SURGICAL, CLIP | GDO | TELEFLEX MEDICAL | IPN915191 | O2-03 | 24026704697841 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | NONE REPORTED| NONE REPORTED| NONE REPORTED| NONE REPORTED |