ABC® BEND-A-BEAM®
Report
- Report Number
- 3007305485-2025-00159
- Event Type
- Malfunction
- Date Received
- September 26, 2025
- Date of Event
- September 12, 2025
- Report Date
- November 19, 2025
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GEI
- PMA / PMN Number
- K961505
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY. H3 OTHER TEXT: DEVICE NOT YET RECEIVED.
NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CAN NOT BE VERIFIED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY REVIEW (DHR) CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4) REPORTS, 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 NOT TO IMMERSE OR SATURATE HAND CONTROL PENCIL OR CORD IN FLUID. 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. USE LOWEST POSSIBLE POWER SETTING ON THE CONMED ABC® ELECTROSURGICAL GENERATOR CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT. USE SHORTEST EFFECTIVE ABC® ACTIVATION TIME NECESSARY. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
UPDATE/DEVICE EVALUATION: REPORTED EVENT OF THE DEVICE CATCHING FIRE WAS INCONCLUSIVE. THE EXAMINATION OF THE RETURNED USED DEVICE 134006 FOUND THAT WHEN PLUGGED INTO THE SYSTEM 7550, THE DEVICE BARELY SPARKED AT ALL. TESTING COULD NOT REPEAT THE REPORTED EVENT. IT IS UNKNOWN WHETHER SUBMERGING THE DEVICE IN WATER WHICH THE CUSTOMER STATES, INFLUENCED THIS DEVICE. HOWEVER, UPON VISUAL INSPECTION THE TIP WAS BURNED ON ONE SIDE OF THE TIP. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A DEVICE HISTORY REVIEW (DHR) CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED NOT TO IMMERSE OR SATURATE HAND CONTROL PENCIL OR CORD IN FLUID. 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. USE LOWEST POSSIBLE POWER SETTING ON THE CONMED ABC® ELECTROSURGICAL GENERATOR CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT. USE SHORTEST EFFECTIVE ABC® ACTIVATION TIME NECESSARY. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 134006, HANDPIECE HAND CONTROL MALLEABLE HANDPIECE,6" (15.2 CM) DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND "AS THE ARGON UNIT WAS ABOUT TO BE USED THE TIP OF THE HANDPIECE CAUGHT ON FIRE AND HAD TO BE SUBMERGED IN WATER. THE UNIT AND THE HANDPIECE WERE BOTH IMMEDIATELY REMOVED FROM THE ROOM.". THE PROCEDURE WAS COMPLETED WITH NO DELAY OR IMPACT TO THE PATIENT OR USER. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 134006, HANDPIECE HANDCONTROL MALLEABLE HANDPIECE,6" (15.2 CM) DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND "AS THE ARGON UNIT WAS ABOUT TO BE USED THE TIP OF THE HANDPIECE CAUGHT ON FIRE AND HAD TO BE SUBMERGED IN WATER. THE UNIT AND THE HANDPIECE WERE BOTH IMMEDIATELY REMOVED FROM THE ROOM.". THE PROCEDURE WAS COMPLETED WITH NO DELAY OR IMPACT TO THE PATIENT OR USER. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 134006, HANDPIECE HANDCONTROL MALLEABLE HANDPIECE,6" (15.2 CM) DEVICE WAS USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2025, AND "AS THE ARGON UNIT WAS ABOUT TO BE USED THE TIP OF THE HANDPIECE CAUGHT ON FIRE AND HAD TO BE SUBMERGED IN WATER. THE UNIT AND THE HANDPIECE WERE BOTH IMMEDIATELY REMOVED FROM THE ROOM.". THE PROCEDURE WAS COMPLETED WITH NO DELAY OR IMPACT TO THE PATIENT OR USER. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. 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 |
|---|---|---|---|---|---|---|---|
| 1935257 | ABC® BEND-A-BEAM® | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |