REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE
Report
- Report Number
- 3007305485-2023-00208
- Event Type
- Malfunction
- Date Received
- September 27, 2023
- Report Date
- October 26, 2023
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- FZQ
- UDI-DI
- 00653405050608
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE IS NOT BEING RETURNED AND THE PHOTOGRAPHIC EVIDENCE PROVIDED DOES NOT APPEAR TO VERIFY THE COMPLAINT; THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 10 COMPLAINTS, REGARDING 17 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO ALWAYS ENSURE TRIGGER IS FULLY CLOSED AND RELEASED TO PROPERLY FEED THE NEXT STAPLE INTO POSITION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
THE CUSTOMER REPORTED THAT THE DEVICE, 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿WE ARE HAVING ISSUES WITH THE SKIN STAPLES RECENTLY AND WAS WANDERING IF WE MAY HAVE A BAD BATCH. THERE HAVE BEEN SEVERAL CONSULTANTS COMPLAINING OF THE SAME ISSUE SAYING THEY ARE NOT CLOSING THE SKIN ON BOTH SIDES JUST ON ONE SIDE. WE HAVE HAD ISSUE POST OPERATIVELY TOO WHERE THE STAPLES ARE COMING LOOSE AND FALLING OUT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PATIENTS WOUND NEEDED TO BE REDRESSED DUE TO A SPOILED DRESSING FROM WOUND COMING OPEN FROM THE STAPLES FALLING OUT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE CUSTOMER REPORTED THAT THE DEVICE, 3013, REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿WE ARE HAVING ISSUES WITH THE SKIN STAPLES RECENTLY AND WAS WANDERING IF WE MAY HAVE A BAD BATCH. THERE HAVE BEEN SEVERAL CONSULTANTS COMPLAINING OF THE SAME ISSUE SAYING THEY ARE NOT CLOSING THE SKIN ON BOTH SIDES JUST ON ONE SIDE. WE HAVE HAD ISSUE POST OPERATIVELY TOO WHERE THE STAPLES ARE COMING LOOSE AND FALLING OUT.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE PATIENTS WOUND NEEDED TO BE REDRESSED DUE TO A SPOILED DRESSING FROM WOUND COMING OPEN FROM THE STAPLES FALLING OUT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 832497 | REFLEX TL, SKIN STAPLER WITH TISSUE LIFT, 35 WIDE | CLIP, REMOVABLE (SKIN) | FZQ | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | 202305194 | 00653405050608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |