BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 11235978 · Received January 27, 2021

    Report

    Report Number
    3007305485-2021-00024
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 6, 2021
    Report Date
    March 19, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION OF THE DEVICE FOUND AN IEC CONNECTOR RETAINING CLAMP IS BAD AND THE SWITCH DOESN'T FUNCTION PROPERLY. PARTS WERE REPLACED, THE DEVICE REPAIRED, THE DEVICE CALIBRATED, AND THE PM PERFORMED; THE DEVICE WAS FINAL TESTED AND MET ALL SPECIFICATIONS. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SERVICE HISTORY WAS REVIEWED, AND NO PREVIOUS SERVICE DATA WAS FOUND. (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED 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. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    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. 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 TESTED BY TWO STAFF MEMBERS WITH THE DEVICE PLUGGED IN; HOWEVER, THE DEVICE WAS TURNED OFF. THE STAFF WERE ATTEMPTING TO PLUG IN A PATIENT PLATE AND A PATIENT PEN (UNKNOWN MANUFACTURER, CATALOG NUMBERS AND SERIAL/LOT NUMBERS) WHEN IT WAS STATED "BOTH PARTS DELIVERED SHOCKS TO THEM AS THEY WERE PLUGGING THEM IN". BOTH FACILITY STAFF MEMBERS CLAIM TO BE FINE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION. THERE WAS NO PATIENT INVOLVEMENT AS THIS WAS NOT DURING A SURGICAL PROCEDURE. 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
    132673 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT PEN| PATIENT PLATE