BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR

    MDR report key: 21457811 · Received February 25, 2025

    Report

    Report Number
    3007305485-2025-00021
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 5, 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

    Additional Manufacturer Narrative · 0

    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 REPORTED EVENT. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 7 REPORTS, REGARDING 7 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: 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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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 (B)(6) 2025 AND ¿SHOCKS TO HIMSELF AND THE PT WHILE USING THE HYFRECATOR. IN ONE INCIDENT THE DOCTOR HAD PUT HIS HAND ON THE PATIENT WHILE USING IT ON THE PATIENT AND THE PATIENT HAD RECEIVE ELECTRIC SHOCKS AND THEN THE DOCTOR WAS RECEIVING THEM WHILE HOLDING THE PENCIL. 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.¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. 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.

    Description of Event or Problem · 0

    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 (B)(6) 2025 AND ¿SHOCKS TO HIMSELF AND THE PT WHILE USING THE HYFRECATOR. IN ONE INCIDENT THE DOCTOR HAD PUT HIS HAND ON THE PATIENT WHILE USING IT ON THE PATIENT AND THE PATIENT HAD RECEIVE ELECTRIC SHOCKS AND THEN THE DOCTOR WAS RECEIVING THEM WHILE HOLDING THE PENCIL. 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.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. 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
    1075845 HYFRECATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown