PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20
Report
- Report Number
- 1320894-2022-00124
- Event Type
- Malfunction
- Date Received
- June 7, 2022
- Date of Event
- May 10, 2022
- Report Date
- June 23, 2022
- Manufacturer
- WICKIMED
- Product Code
- GEI
- PMA / PMN Number
- K103375
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
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.
CORRECTION: D3 AND G1 ADDRESSES WERE CORRECTED (ADDRESS CITY AND POSTAL CODE). MANUFACTURER NARRATIVE: REPORTED EVENT OF THE PLUME PEN SPARKING IS UNCONFIRMED. RECEIVED ONE PLP2020 IN UNORIGINAL PACKAGE. LOT NUMBER NOT VERIFIED. PERFORMED A VISUAL INSPECTION, NO ABNORMALITIES OR DEFECTS CONFIRMED. PERFORMED A FUNCTIONAL INSPECTION USING THE ARGON SYSTEM 7750 (8406), THE DEVICE FUNCTIONED AS INTENDED. A TWO-YEAR LOT HISTORY REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED SINCE A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 6 REPORTS, REGARDING 6 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 THE FOLLOWING: INSPECT INSTRUMENTS AND CABLES FOR DAMAGE PRIOR TO EACH USE, ESPECIALLY THE INSULATION OF LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS. THIS MAY BE DONE VISUALLY UNDER MAGNIFICATION OR WITH A HIGH VOLTAGE INSULATION TESTING DEVICE. INSULATION FAILURES MAY RESULT IN BURNS OR OTHER INJURIES TO THE PATIENT OR OPERATOR. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL WAS BEING USED ON (B)(6) 2022 DURING A TONSILLECTOMY AND THE ¿SURGEON WAS USING PLP2020 FOR A TONSILLECTOMY. SCRUB HAD SWAPPED OUT ORIGINAL ELECTRODE FOR A MEGADYNE INSULATED NEEDLE TIP ELECTRODE. FIRST TIME SURGEON PRESSED 'CUT', A SPARK BURST FROM THE ELECTRODE HOUSING ON THE DISTAL END OF THE HANDPIECE (NOT THE DISTAL END OF THE ELECTRODE) AND THE PATIENTS LIP RECEIVED A MINOR BURN. THEY (REPORTER)BELIEVE THAT THE ELECTRODE MAY NOT HAVE BEEN PUSHED IN THE ENTIRE WAY, BUT THIS CANNOT BE ENTIRELY VERIFIED.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE STANDARD NON-PLUME BOVIE PENCIL. THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE. THE MEGADYNE ELECTRODE USED WAS MEGADYNE #: 0012 AND LOT #: 190273. THE MEGADYNE WILL BE LISTED AS A CONCOMITANT DEVICE. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE PATIENT HAD A ¿MINOR BURN ON LIP. FACILITY IS NOT BLAMING THE HANDPIECE, THEY ARE LEANING MORE TOWARDS USER ERROR, BUT WANT EQUIPMENT ANALYZED. ELECTRODE THAT WAS INVOLVED UNFORTUNATELY WAS DISPOSED OF, BUT IT WAS AN INSULATED ELECTRODE AND THERE IS ALSO THOUGHT INSULATION ON MEGADYNE ELECTRODE COULD HAVE BEEN DEFECTIVE. THANKFULLY, PATIENT IS OK. 1ST DEGREE BURN NO TREATMENT WAS NEEDED.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ANY PROLONGED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, PLP2020, PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL WAS BEING USED ON (B)(6) 2022 DURING A TONSILLECTOMY AND THE ¿SURGEON WAS USING PLP2020 FOR A TONSILLECTOMY. SCRUB HAD SWAPPED OUT ORIGINAL ELECTRODE FOR A MEGADYNE INSULATED NEEDLE TIP ELECTRODE. FIRST TIME SURGEON PRESSED 'CUT', A SPARK BURST FROM THE ELECTRODE HOUSING ON THE DISTAL END OF THE HANDPIECE (NOT THE DISTAL END OF THE ELECTRODE) AND THE PATIENTS LIP RECEIVED A MINOR BURN. THEY (REPORTER)BELIEVE THAT THE ELECTRODE MAY NOT HAVE BEEN PUSHED IN THE ENTIRE WAY, BUT THIS CANNOT BE ENTIRELY VERIFIED.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE STANDARD NON-PLUME BOVIE PENCIL. THERE WAS A 15 MINUTE DELAY TO THE PROCEDURE. THE MEGADYNE ELECTRODE USED WAS MEGADYNE #: 0012 AND LOT #: 190273. THE MEGADYNE WILL BE LISTED AS A CONCOMITANT DEVICE. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE PATIENT HAD A ¿MINOR BURN ON LIP. FACILITY IS NOT BLAMING THE HANDPIECE, THEY ARE LEANING MORE TOWARDS USER ERROR, BUT WANT EQUIPMENT ANALYZED. ELECTRODE THAT WAS INVOLVED UNFORTUNATELY WAS DISPOSED OF, BUT IT WAS AN INSULATED ELECTRODE AND THERE IS ALSO THOUGHT INSULATION ON MEGADYNE ELECTRODE COULD HAVE BEEN DEFECTIVE. THANKFULLY, PATIENT IS OK. 1ST DEGREE BURN NO TREATMENT WAS NEEDED.¿ THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ANY PROLONGED 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 |
|---|---|---|---|---|---|---|---|
| 1122710 | PLUMEPEN ELITE SURGICAL SMOKE EVAC PENCIL, 10FT TUBING,QTY20 | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | WICKIMED | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Female | MEGADYNE ELECTRODE| MEGADYNE ELECTRODE |