BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 10246889 · Received July 8, 2020

    Report

    Report Number
    1720159-2020-00271
    Event Type
    Injury
    Date Received
    July 8, 2020
    Date of Event
    June 9, 2020
    Report Date
    July 8, 2020
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED THEREFORE ROOT CAUSE CANNOT BE IDENTIFIED. 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. FROM THE SERIAL NUMBER, THE DEVICE WAS MANUFACTURED IN 2012. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN 10 COMPLAINTS REGARDING 10 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME 34,979 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE .0003 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HYFRECATOR 2000, 7-900-115, WAS USED IN A NECK PROCEDURE ON (B)(6) 2020. THE DOCTOR WAS PERFORMING A PROCEDURE ON THE PATIENT'S NECK AND THE PATIENT FELT SOMETHING LIKE AN ELECTRIC SHOCK. AFTER THE PROCEDURE THE PATIENT NOTICED A BURN ON HER PINKIE FINGER FROM THE PROCEDURE. MULTIPLE ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN MADE, BUT TO DATE NO NEW INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED AS PATIENT INJURY, DUE TO UNKNOWN DEGREE OF BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709761 HYFRECATOR 2000, 115V ELECTROSURGICAL UNIT GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other