HYFRECATOR
Report
- Report Number
- 3007305485-2025-00022
- Event Type
- Malfunction
- Date Received
- February 25, 2025
- Report Date
- April 7, 2025
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GEI
- PMA / PMN Number
- K970493
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
HYFRECATOR 2000 SERIAL NO: (B)(6) PASSES ALL TEST CRITERIA. TESTED PENCIL SUPPLIED. PASSES TEST CRITERIA. ADVISE POWER CORD NOT PLUGGED IN PROPERLY. POWER CORD MUST BE PLUGGED IN CORRECTLY TO CREATE PROPER GRD. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR DATA WAS FOUND. A DEVICE HISTORY RECORD REVIEW FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS REPORTAL OF 7 REPORTS, REGARDING 7 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: TO MINIMIZE THE POSSIBILITY OF SHOCKING DURING MONOTERMINAL APPLICATIONS, DO NOT LET YOUR PATIENT COME IN CONTACT WITH ANY GROUNDED METAL OBJECTS. POSITION THE ELECTRODE ON OR CLOSE TO THE PATIENT BEFORE ACTIVATING THE OUTPUT. FOR PROCEDURES USING THE DISPERSIVE PLATE, DO NOT ALLOW THE PATIENT TO BREAK CONTACT WITH THE DISPERSIVE PLATE WHEN THE UNIT IS ACTIVATED. IF THE PHYSICIAN OR NURSE MUST TOUCH THE PATIENT, PLACE HAND ON THE PATIENT BEFORE ACTIVATING THE HYFRECATOR® 2000. DO NOT BREAK CONTACT DURING ACTIVATION. TO LESSEN THE POSSIBILITY OF A SHOCK, WEAR GLOVES AT ALL TIMES AND CONTINUE TO AVOID CONTACT WITH GROUNDED METAL OBJECTS. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
THE REPORTED DEVICE HAS BEEN RETURNED TO CONMED; HOWEVER, THE INVESTIGATION OF THE DEVICE HAS NOT BEEN COMPLETED. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 7-900-230 HYFRECATOR 2000 230 VOLTS AC - 50/60 HZ ELECTROSURGICAL UNIT WAS BEING USED ON AN UNKNOWN DATE AND ¿¿SHOCKS TO HIMSELF AND THE PT WHILE USING THE HYFRECATOR. ¿INITIALLY, THE DOCTOR BELIEVED IT WAS AN ISOLATED INCIDENT, BUT SIMILAR OCCURRENCES HAVE SINCE BEEN REPORTED BY OTHER DOCTORS IN OUR PRACTICE. WE HAD A QUALIFIED ELECTRICIAN ASSESS THE MACHINE, BUT HE FOUND NO FAULTS WITHIN THE UNIT ITSELF. HOWEVER, HE NOTED SOME SMALL KINKS IN THE CABLE CONNECTING THE MACHINE TO THE HAND-SWITCHING PENCIL. WHILE THESE KINKS WERE NOT EASILY VISIBLE IN THE PROVIDED PHOTO, THEY MAY BE CONTRIBUTING TO THE ISSUE.¿. FURTHER ASSESSMENT HAS BEEN REQUESTED; HOWEVER, TO DATE NO INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 7-900-230 HYFRECATOR 2000 230 VOLTS AC - 50/60 HZ ELECTROSURGICAL UNIT WAS BEING USED ON AN UNKNOWN DATE AND ¿SHOCKS TO HIMSELF AND THE PT WHILE USING THE HYFRECATOR. INITIALLY, THE DOCTOR BELIEVED IT WAS AN ISOLATED INCIDENT, BUT SIMILAR OCCURRENCES HAVE SINCE BEEN REPORTED BY OTHER DOCTORS IN OUR PRACTICE. WE HAD A QUALIFIED ELECTRICIAN ASSESS THE MACHINE, BUT HE FOUND NO FAULTS WITHIN THE UNIT ITSELF. HOWEVER, HE NOTED SOME SMALL KINKS IN THE CABLE CONNECTING THE MACHINE TO THE HAND-SWITCHING PENCIL. WHILE THESE KINKS WERE NOT EASILY VISIBLE IN THE PROVIDED PHOTO, THEY MAY BE CONTRIBUTING TO THE ISSUE.¿. FURTHER ASSESSMENT HAS BEEN REQUESTED; HOWEVER, TO DATE NO INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1075842 | HYFRECATOR | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | CONSOLIDATED MEDICAL EQUIPMENT COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |