BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-HELD HOOK TIP COAGULATOR

    MDR report key: 153030 · Received February 23, 1998

    Report

    Report Number
    1825883-1998-00002
    Event Type
    Malfunction
    Date Received
    February 23, 1998
    Date of Event
    January 21, 1998
    Report Date
    February 20, 1998
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ELECTROCAUTERY UNIT WAS BEING USED TO CUT THE CAPSULE IN A PATIENT'S KNEE. WHEN THE PROCEDURE WAS COMPLETE THE UNIT WAS REMOVED FROM THE KNEE, BUT WOULD NOT SHUT OFF. SEVERAL ATTEMPTS AT PRESSING THE BUTTON WERE MADE BEFORE IT WOULD SHUT OFF. THE UNIT WAS THEN DISCARDED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other