BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-HELD HOOK TIP COAGULATOR

    MDR report key: 149560 · Received February 13, 1998

    Report

    Report Number
    1825883-1998-00001
    Event Type
    Malfunction
    Date Received
    February 13, 1998
    Date of Event
    January 12, 1998
    Report Date
    February 13, 1998
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO CONFIRM OR RECREATE THE FAILURE. IF ADD'L FAILURES OCCUR, THE DEVICES WILL CONTINUE TO BE EVALUATED FOR CAUSE OF FAILURE.

    Description of Event or Problem · 1

    ELECTROCAUTERY PEN UNIT WAS OPERATING CORRECTLY, TURNED OFF, AND PLACED INTO THE HOLSTER. WHEN IT WAS RETRIEVED FROM THE HOLSTER, IT HAD SPONTANEOUSLY ACTIVATED. THE UNIT WAS UNPLUGGED AND REPLACED WITH ANOTHER UNIT THAT ALSO SPONTANEOUSLY ACTIVATED UNDER THE SAME CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAND-HELD HOOK TIP COAGULATOR HAND OPERATED ELECTROSURGICAL CAUTERY PEN GEI INSTRUMENT MAKAR, INC. 10798 021160

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other