BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR 2000 115V

    MDR report key: 9955143 · Received April 13, 2020

    Report

    Report Number
    1720159-2020-00186
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    March 17, 2020
    Report Date
    May 6, 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 · 0

    EVALUATION OF DEVICE 7-900-115 FOUND THAT RIBBON CABLE AND STRAIT CONNECTOR WERE DAMAGED, ALSO THERE WAS A MISSING HEAT SINK ON A2VR1. ADDITIONALLY, THE PREVENTIVE MAINTENANCE WAS OVERDUE . A DHR REVIEW WAS NOT CONDUCTED AS THE DEVICE HAS BEEN IN THE FIELD GREATER THAN 12 MONTHS. THE SERVICE HISTORY WAS REVIEWED, AND NO PRIOR DATA WAS FOUND. (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 MAINS 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 REPORTED DEVICE IS EXPECTED TO BE RETURNED TO CONMED FOR EVALUATION AND THE COMPLAINT INVESTIGATION IS ON-GOING. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND 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 7-900-115, HYFRECATOR 2000, 115V, MAY HAVE SHOCKED A PERSON. IT IS NOT KNOWN FOR SURE IF THE UNIT SHOCKED THE PERSON, BUT THE FACILITY WANTED THE MACHINE CHECKED OUT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, BUT TO DATE THERE IS NO NEW INFORMATION TO ADD. THE INVESTIGATION IS ONGOING. THIS REPORT IS BEING RAISED AS AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417259 HYFRECATOR 2000 115V ELECTROSURGICAL UNIT GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other