HYFRECATOR
Report
- Report Number
- 3007305485-2024-00102
- Event Type
- Malfunction
- Date Received
- July 17, 2024
- Date of Event
- May 18, 2024
- Report Date
- August 9, 2024
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GEI
- PMA / PMN Number
- K970493
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- 003
Narratives
THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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.
CORRECTION: BRAND NAME HAS BEEN CORRECTED IN SECTION D.1. MANUFACTURER NARRATIVE: THE DEVICE WAS OVERDUE FOR PREVENTATIVE MAINTENANCE. NO FAULT WAS FOUND DURING THE EVALUATION, AND NO ADDITIONAL PROBLEMS WERE FOUND. 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. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR DATA WAS FOUND. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 7 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 THE FOLLOWING: DO NOT USE THE HANDSWITCHED PENCIL WITH A FOOTSWITCH. THE UNCONNECTED SWITCH CONNECTOR CAN ARC TO NEARBY OBJECTS OR PERSONNEL AND CAUSE A BURN. ADDITIONALLY, THE IFU STATES THE HYFRECATOR® 2000 SHOULD BE TESTED BY QUALIFIED SERVICE PERSONNEL ON A PERIODIC BASIS. CONMED SUGGESTS EXAMINATION OF THE UNIT AT LEAST EVERY 12 MONTHS. WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 7-900-230, HYFRECATOR 2000, 230V DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON (B)(6) 2024, AND ¿ITEM DANGEROUSLY FAILED DURING PATIENT USE. IT WAS REPORTED THAT AN ARC OF ELECTRICITY SHOT OUT OF THE HAND-PIECE AND SET FIRE TO A CURTAIN.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, AND THERE WAS NO IMPACT TO THE PATIENT OR USER. FOLLOW-UP ASSESSMENT CONFIRMED THAT NO PATIENT OR USER WAS INJURED IN THE EVENT. THE CUSTOMER INDICATED THAT NO FURTHER DETAILS WERE AVAILABLE. 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 7-900-230, HYFRECATOR 2000, 230V DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON (B)(6) 2024, AND ¿ITEM DANGEROUSLY FAILED DURING PATIENT USE. IT WAS REPORTED THAT AN ARC OF ELECTRICITY SHOT OUT OF THE HAND-PIECE AND SET FIRE TO A CURTAIN.¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE, AND THERE WAS NO IMPACT TO THE PATIENT OR USER. FOLLOW-UP ASSESSMENT CONFIRMED THAT NO PATIENT OR USER WAS INJURED IN THE EVENT. THE CUSTOMER INDICATED THAT NO FURTHER DETAILS WERE AVAILABLE. 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 |
|---|---|---|---|---|---|---|---|
| 2047033 | HYFRECATOR | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |