PENCIL,ABC,BEND-A-BEAM,6" LONG
Report
- Report Number
- 3007305485-2022-00169
- Event Type
- Malfunction
- Date Received
- November 2, 2022
- Report Date
- December 21, 2022
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GEI
- PMA / PMN Number
- K961505
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- 501
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.
REPORTED EVENT ¿DEFECTIVE AND WAS CATCHING ON FIRE¿ WAS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE AND DEVICE EVALUATION. RECEIVED ONE 134006 IN ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THE DEVICE WAS RECEIVED WITH THE TUBING AND WIRING CUT. THE VISUAL INSPECTION SHOWS MELTING ON THE DISTAL TIP OF THE DEVICE AS WELL AS CHARRING. 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 5 COMPLAINTS, REGARDING 5 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 189,850 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: THE USER IS ADVISED DO NOT DIRECTLY SECURE THE CABLE WITH METAL INSTRUMENTS TO SURGICAL DRAPES. ACTIVATION OF THE DEVICE IN CONTACT WITH METAL INSTRUMENTS MAY CAUSE BURNS AT THE TISSUE/INSTRUMENT INTERFACE. DO NOT PERMIT CABLES CONNECTED TO ASSOCIATED ELECTROSURGICAL ACCESSORIES TO BE PARALLEL TO OR IN CLOSE PROXIMITY TO THE LEADS OF OTHER ELECTRICAL DEVICES. USE OF THE HANDPIECE WITH INSUFFICIENT ARGON GAS FLOW MAY SEVERELY DAMAGE THE TIP. DO NOT PULL ON OR STRETCH THE HANDPIECE CORD. DO NOT TEST THE CONMED ABC® ELECTROSURGICAL GENERATOR BY SPARKING THE ACTIVE ELECTRODE TO THE PATIENT PLATE OR OTHER OBJECTS. 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 134006, PENCIL, ABC, BEND-A-BEAM,6" LONG WAS BEING USED DURING A LIVER TRANSPLANT ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿I WAS TOLD THAT THE ARGON USED DURING LIVER TRANSPLANT WAS PROBABLY DEFECTIVE AND WAS CATCHING ON FIRE (LITERALLY FLAMES). THE CUSTOMER IS THINKING THE ISSUE IS THE INNER TUBING IS SHORTER AND IT CAUSES THE HEAT TO START BURNING THE OUTER BLACK RUBBER COATING.¿ FURTHER ASSESSMENT FOUND THAT THERE WAS NO FRAGMENTATION OF THE BLACK RUBBER COATING, AND THERE WAS NO REPORTED BURN TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS WITH NO REPORT OF DELAY. THE PATIENT¿S CURRENT STATUS WAS REPORTED AS ¿OK, NO ISSUES¿ THERE WAS ALSO 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.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 134006, PENCIL, ABC, BEND-A-BEAM,6" LONG WAS BEING USED DURING A LIVER TRANSPLANT ON AN UNKNOWN DATE WHEN IT WAS REPORTED ¿I WAS TOLD THAT THE ARGON USED DURING LIVER TRANSPLANT WAS PROBABLY DEFECTIVE AND WAS CATCHING ON FIRE (LITERALLY FLAMES). THE CUSTOMER IS THINKING THE ISSUE IS THE INNER TUBING IS SHORTER AND IT CAUSES THE HEAT TO START BURNING THE OUTER BLACK RUBBER COATING.¿ FURTHER ASSESSMENT FOUND THAT THERE WAS NO FRAGMENTATION OF THE BLACK RUBBER COATING, AND THERE WAS NO REPORTED BURN TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED AS WITH NO REPORT OF DELAY. THE PATIENT¿S CURRENT STATUS WAS REPORTED AS ¿OK, NO ISSUES¿ THERE WAS ALSO 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 |
|---|---|---|---|---|---|---|---|
| 1911066 | PENCIL,ABC,BEND-A-BEAM,6" LONG | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | 202203294 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |