PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL
Report
- Report Number
- 1320894-2022-00219
- Event Type
- Malfunction
- Date Received
- October 26, 2022
- Date of Event
- September 21, 2022
- Report Date
- December 15, 2022
- Manufacturer
- ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD.
- Product Code
- GEI
- UDI-DI
- 20845854061227
- PMA / PMN Number
- K103375
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
TO DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN 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 29 COMPLAINTS, REGARDING 41 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 THAT THE PLUMEPEN®ULTRA IS EQUIPPED WITH SEVERAL KEY FEATURES FOR THE SURGEON¿S CONVENIENCE. SURROUNDING THE ELECTRODE BLADE IS A TRANSLUCENT PLASTIC TUBE THAT ALLOWS THE BLADE AND TUBE TO BE POSITIONED AT VARYING LENGTHS TO MOST EFFECTIVELY CAPTURE SURGICAL SMOKE PLUME AS IT IS CREATED. ROTATE THE CAM LOCKING MECHANISM TO THE UNLOCK POSITION. EXTEND CAPTURE PORT / BLADE TO DESIRED LENGTH. PLEASE NOTE CAPTURE PORT AND BLADE MOVE TOGETHER. TURN THE CAM LOCKING MECHANISM BACK TO THE LOCK POSITION AND ENSURE THAT THE TUBE IS SECURELY LOCKED IN PLACE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY. DEVICE NOT YET RECEIVED.
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5112276) ON 12OCT22. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST PLPUL2520, PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE THAT OCCURRED ON (B)(6) 2022. THE REPORT STATED, ¿WHILE USING THE PLUMEPEN SMOKE EVACUATION PENCIL BOVIE, DURING SURGICAL PROCEDURE, THE BLADE FELL OUT WHILE IN USE AT THE SURGICAL SITE. ALSO NOTED THAT A PLASTIC PIECE FROM INSIDE THE PLASTIC SHEATH ON THE DISTAL END OF THE BOVIE FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED. THE PATIENT WAS NOT INJURED AS A RESULT OF THIS EVENT.¿. THE COMPONENT WAS RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5112276) ON 12OCT22. THE CURRENT COMPLAINT DATABASE HAS BEEN RESEARCHED FOR THIS EVENT AND THERE WERE NO FINDINGS. THE REPORT WAS FOUND TO BE WRITTEN AGAINST PLPUL2520, PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL. IT WAS STATED THAT THE DEVICE WAS BEING USED DURING AN UNKNOWN PROCEDURE THAT OCCURRED ON (B)(6) 2022. THE REPORT STATED, ¿WHILE USING THE PLUMEPEN SMOKE EVACUATION PENCIL BOVIE, DURING SURGICAL PROCEDURE, THE BLADE FELL OUT WHILE IN USE AT THE SURGICAL SITE. ALSO NOTED THAT A PLASTIC PIECE FROM INSIDE THE PLASTIC SHEATH ON THE DISTAL END OF THE BOVIE FELL INTO THE PATIENT. THE PIECE WAS RETRIEVED. THE PATIENT WAS NOT INJURED AS A RESULT OF THIS EVENT.¿. THE COMPONENT WAS RETRIEVED FROM THE PATIENT. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2556517 | PLUMEPEN ULTRA SURGICAL SMOKE EVACUATION PENCIL | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | ZHEJIANG SHUYOU SURGICAL INSTRUMENT CO., LTD. | PLPUL2520 | 041722 | 20845854061227 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |