BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 10960944 · Received December 7, 2020

    Report

    Report Number
    3007305485-2020-00537
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 10, 2020
    Report Date
    January 26, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE HAS BEEN PROVIDED; THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. THE SERVICE HISTORY WAS REVIEWED, AND NO DATA WAS FOUND. A DHR REVIEW WAS NOT CONDUCTED AS THE DEVICE HAS BEEN IN THE FIELD FOR MORE THAN 12 MONTHS. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: TO AVOID ALTERNATE SITE BURNS OR POTENTIAL SHOCK, REMOVE ALL METAL OBJECTS FROM TREATMENT AREA BEFORE USING THE HYFRECATOR 2000. IT IS NOT ADVISABLE TO USE THIS INSTRUMENT IN THE PROXIMITY OF JEWELRY, EYEGLASSES, DIGITAL WATCHES, PORTABLE RADIOS, POCKET CALCULATORS, HEARING AIDS, ETC. TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH. THE HYFRECATOR SHOULD BE TESTED BY QUALIFIED SERVICE PERSONNEL ON A PERIODIC BASIS. CONMED SUGGESTS EXAMINATION OF THE UNIT AT LEAST EVERY 12 MONTHS. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE 7-900-115 WAS BEING USED DURING A PROCEDURE ON (B)(6) 2020 WHEN IT WAS REPORTED THAT "THE PATIENT WAS NOT GROUNDED (NOR DID HE NEED TO BE GROUNDED) FREQUENCY WAS 'HIGH' AT 24 HE FELT A SHOCK ON TWO SEPARATE OCCASIONS SO DR ACKERMAN ABORTED THE PROCEDURE AND THEREAFTER RESORTED TO HEAT CAUTERY AND PRESSURE." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT DUE TO THIS EVENT. 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
    1423083 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1