20/CA ULTRA NONSTICK 10FT
Report
- Report Number
- 1320894-2023-00160
- Event Type
- Malfunction
- Date Received
- August 15, 2023
- Date of Event
- June 20, 2023
- Report Date
- September 19, 2023
- Manufacturer
- ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD.
- Product Code
- GEI
- PMA / PMN Number
- K103375
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTION: THE PREVIOUS STATEMENT OF "PHOTOGRAPHIC EVIDENCE PROVIDED DOES NOT APPEAR TO VERIFY THE COMPLAINT; THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED". HAS BEEN CORRECTED TO "NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION CANNOT BE VERIFIED". MANUFACTURER NARRATIVE: THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, A DEVICE MALFUNCTION 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 34 COMPLAINTS, REGARDING 45 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 4,077,920 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 0.00001. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED IF NECESSARY TO REMOVE BLADE: UNPLUG THE PENCIL. ENSURE THAT CAM IS IN THE LOCK POSITION. USE A SURGICAL CLAMP AND PULL BLADE FORWARD. REPLACE WITH BLADE OF CHOICE. CONFIRM THAT BLADE IS COMPLETELY INSERTED AND SECURE BEFORE ACTIVATING PENCIL. NEVER FORCE THE BLADE INTO THE PENCIL. CAUTION: WE DO NOT RECOMMEND RE-USING THE ORIGINAL BLADE AFTER IT HAS BEEN REMOVED. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
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 34 COMPLAINTS, REGARDING (B)(4) 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 IF NECESSARY TO REMOVE BLADE: UNPLUG THE PENCIL. ENSURE THAT CAM IS IN THE LOCK POSITION. USE A SURGICAL CLAMP AND PULL BLADE FORWARD. REPLACE WITH BLADE OF CHOICE. CONFIRM THAT BLADE IS COMPLETELY INSERTED AND SECURE BEFORE ACTIVATING PENCIL. NEVER FORCE THE BLADE INTO THE PENCIL. CAUTION: WE DO NOT RECOMMEND RE-USING THE ORIGINAL BLADE AFTER IT HAS BEEN REMOVED. 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.
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT 3301250000-2023-8002 ON 27JUL23. THE REPORT WAS FOUND TO BE WRITTEN AGAINST PLPUL2020, 20/CA ULTRA NONSTICK 10FT, THAT WAS BEING USED DURING A GYN ONCOLOGY PROCEDURE ON 20JUN23. THE REPORT STATED, ¿DURING PROCEDURE, THE SMOKE EVACTUATION PENCIL BOVIE WAS ABOUT TO BE USED. WHEN IT WAS NOTICED TO BE DAMAGED WITH BOVIE TIP OFFSET. THE BOVIE TIP AREA WHERE PLASTIC HOLDS THE TIP IN PLACE BROKE OFF AND FELL INTO PATIENT. THE PLASTIC SHARD WAS RETRIEVED WITH NO OTHER PIECES FOUND UPON EXAMINATION. IRRIGATION DID OCCUR WITH NO FURTHER PIECES BEING FOUND.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (B)(4) ON 27JUL23. THE REPORT WAS FOUND TO BE WRITTEN AGAINST PLPUL2020, 20/CA ULTRA NONSTICK 10FT, THAT WAS BEING USED DURING A GYN ONCOLOGY PROCEDURE ON (B)(6) 2023. THE REPORT STATED, ¿DURING PROCEDURE, THE SMOKE EVACUATION PENCIL BOVIE WAS ABOUT TO BE USED. WHEN IT WAS NOTICED TO BE DAMAGED WITH BOVIE TIP OFFSET. THE BOVIE TIP AREA WHERE PLASTIC HOLDS THE TIP IN PLACE BROKE OFF AND FELL INTO PATIENT. THE PLASTIC SHARD WAS RETRIEVED WITH NO OTHER PIECES FOUND UPON EXAMINATION. IRRIGATION DID OCCUR WITH NO FURTHER PIECES BEING FOUND.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (B)(4) ON 27JUL23. THE REPORT WAS FOUND TO BE WRITTEN AGAINST PLPUL2020, 20/CA ULTRA NONSTICK 10FT, THAT WAS BEING USED DURING A GYN ONCOLOGY PROCEDURE ON (B)(6) 2023. THE REPORT STATED, ¿DURING PROCEDURE, THE SMOKE EVACTUATION PENCIL BOVIE WAS ABOUT TO BE USED. WHEN IT WAS NOTICED TO BE DAMAGED WITH BOVIE TIP OFFSET. THE BOVIE TIP AREA WHERE PLASTIC HOLDS THE TIP IN PLACE BROKE OFF AND FELL INTO PATIENT. THE PLASTIC SHARD WAS RETRIEVED WITH NO OTHER PIECES FOUND UPON EXAMINATION. IRRIGATION DID OCCUR WITH NO FURTHER PIECES BEING FOUND.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1707418 | 20/CA ULTRA NONSTICK 10FT | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD. | 073122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female |