HYFRECATOR
Report
- Report Number
- 3007305485-2024-00089
- Event Type
- Injury
- Date Received
- June 21, 2024
- Report Date
- August 5, 2024
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GEI
- PMA / PMN Number
- K001159
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTION: D1 HAS BEEN UPDATED FROM SHORT DESCRIPTION TO BRAND NAME. MANUFACTURER NARRATIVE: THE DEVICE WILL NOT BE RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. A DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. A TWO-YEAR LOT HISTORY REVIEW CANNOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED TO AVOID BURNS NEVER ALLOW CABLE ASSOCIATED WITH THIS DEVICE TO BE IN CONTACT WITH SKIN OF PATIENT OR TOUCHING OPERATOR. PROLONGED USE OF THE HANDPIECE CAUSES THE ELECTRODE TO BECOME VERY HOT AND THE TIP REMAINS HOT FOR A PERIOD AFTER USE. DO NOT ALLOW THE TIP TO COME IN CONTACT WITH THE PATIENT OR OTHERS AFTER ACTIVATION TO AVOID BURNS. ALWAYS PLACE ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION, SUCH AS A HOLSTER, WHEN NOT IN USE, TO AVOID BURNS. USE LOWEST POSSIBLE POWER SETTING ON THE CONMED® HYFRECATOR® 2000 ELECTROSURGICAL GENERATOR AND SHORTEST POSSIBLE ACTIVATION TIME CAPABLE OF ACHIEVING THE DESIRED SURGICAL EFFECT. 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 CUSTOMER REPORTED THAT THE DEVICE, 7-900-5, PENCIL, H2K, PUSHBUTTON, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿DURING SURGERY THE PENCIL CAUGHT ON FIRE BURNING THE DOCTOR AND PATIENT (RABBIT).¿. FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER; HOWEVER, TO DATE NO ANSWERS HAVE BEEN RECEIVED. THE DEVICE, 7-900-115, HYFRECATOR 2000, 115V, IS THE CONCOMITANT DEVICE USED IN THIS PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF UNKNOWN DEGREE OF BURN TO PATIENT.
THE CUSTOMER REPORTED THAT THE DEVICE, 7-900-5, PENCIL, H2K, PUSHBUTTON, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿DURING SURGERY THE PENCIL CAUGHT ON FIRE BURNING THE DOCTOR AND PATIENT (RABBIT).¿. FURTHER ASSESSMENT WAS REQUESTED FROM THE REPORTER; HOWEVER, TO DATE NO ANSWERS HAVE BEEN RECEIVED. THE DEVICE, 7-900-115, HYFRECATOR 2000, 115V, IS THE CONCOMITANT DEVICE USED IN THIS PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF UNKNOWN DEGREE OF BURN TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204848 | HYFRECATOR | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other | 7-900-115, HYFRECATOR 2000, 115V |