BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-HELD HOOK TIP COAGULATOR

    MDR report key: 161561 · Received April 3, 1998

    Report

    Report Number
    1825883-1998-00005
    Event Type
    Malfunction
    Date Received
    April 3, 1998
    Date of Event
    March 4, 1998
    Report Date
    March 4, 1998
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE COAGULATOR, A NUMBER OF SMALL PIECES OF COATING ON THE ELECTRODE CAME OFF IN THE PT'S KNEE. THE PIECES WERE REMOVED BY CONTINUOUS INFLOW OF GLYCINE AND SUCTION. THE COAGULATOR WAS BEING USED IN A "BLEND MODE" BY DEPRESSION BOTH THE CUT AND COAGULATION BUTTONS SIMULTANEOUSLY. AFTER THE DEVICE WAS REMOVED FROM THE KNEE AND SET ASIDE IT SPONTANEOUSLY ACTIVATED IN THE CUT MODE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention