BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR

    MDR report key: 24816637 · Received April 8, 2026

    Report

    Report Number
    3007305485-2026-00050
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 8, 2026
    Manufacturer
    CONMED
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY. H3 OTHER TEXT: DEVICE NOT YET RECEIVED.

    Description of Event or Problem · 0

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 7-900-230, HYFRECATOR 2000 230 VOLTS AC - 50/60 HZ ELECTROSURGICAL UNIT, WAS BEING PRE-OP TESTED FOR AN UNKNOWN PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿DOCTOR BURNT HIS ARM WHILE USING THE HYFRECATOR. NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS STAGE.¿ THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE HAS BEEN NO ALLEGATION OF DEVICE MALFUNCTION. FURTHER ASSESSMENT HAS BEEN REQUESTED TO DETERMINE THE DEGREE OF BURN; HOWEVER, TO DATE WE HAVE NOT RECEIVED A RESPONSE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF UNKNOWN DEGREE OF BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878157 HYFRECATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other