HELIXAR ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR120V
Report
- Report Number
- 1017294-2023-00073
- Event Type
- Malfunction
- Date Received
- August 11, 2023
- Date of Event
- July 24, 2023
- Report Date
- September 13, 2023
- Manufacturer
- CONMED LARGO
- Product Code
- GEI
- PMA / PMN Number
- K152860
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE SERVICE HISTORY WAS REVIEWED AND NO RELATIONSHIP TO THIS COMPLAINT WAS FOUND. A DEVICE HISTORY REVIEW WAS NOT CONDUCTED AS THE DEVICE HAS BEEN IN THE FIELD GREATER THAN 12 MONTHS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 1 COMPLAINT, REGARDING 1 DEVICE, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME 508 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 0.002. 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.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 60-8800-120, HELIXAR ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR120V WAS BEING USED DURING A LIVER TRANSPLANT PROCEDURE ON (B)(6) 2023 DATE WHEN IT WAS REPORTED ¿WHILE USING THE MONOPOLAR ON THE HELIX ARGON ESU AT THE START OF THE CASE TO MAKE THEIR INCISION THE ANESTHESIOLOGIST FELT A SHOCK. THE CIRCULATING NURSE EXPLAINED THAT EVERYTHING WAS SETUP CORRECTLY WITH THE APPROPRIATE GROUNDING PAD.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE VALLEY LAB FT10 DEVICE AND A 2-MINUTE DELAY WAS ALSO REPORTED. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿STABLE¿. 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.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE 60-8800-120, HELIXAR ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR120V WAS BEING USED DURING A LIVER TRANSPLANT PROCEDURE ON (B)(6) 2023 DATE WHEN IT WAS REPORTED ¿WHILE USING THE MONOPOLAR ON THE HELIX ARGON ESU AT THE START OF THE CASE TO MAKE THEIR INCISION THE ANESTHESIOLOGIST FELT A SHOCK. THE CIRCULATING NURSE EXPLAINED THAT EVERYTHING WAS SETUP CORRECTLY WITH THE APPROPRIATE GROUNDING PAD.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE VALLEY LAB FT10 DEVICE AND A 2-MINUTE DELAY WAS ALSO REPORTED. THE CURRENT STATUS OF THE PATIENT WAS REPORTED AS ¿STABLE¿. 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 |
|---|---|---|---|---|---|---|---|
| 595082 | HELIXAR ELECTROSURGICAL UNIT WITH ARGON BEAM COAGULATOR120V | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONMED LARGO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | VALLEY LAB FT10.| VALLEY LAB FT10. |