BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-HELD HOOK TIP COAGULATOR

    MDR report key: 163871 · Received April 17, 1998

    Report

    Report Number
    1825883-1998-00006
    Event Type
    Malfunction
    Date Received
    April 17, 1998
    Date of Event
    March 17, 1998
    Report Date
    March 17, 1998
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ELECTROCAUTERY UNIT WAS BEING USED FOR ARTHROSCOPIC CAUTERY OF THE SHOULDER. ON RELEASE OF THE COAGULATION BUTTON, THE DEVICE REMAINED IN THE "ON" MODE. THE GENERATOR WAS TURNED OFF AND THE DEVICE WAS REMOVED FROM THE SHOULDER. THE PT WAS NOT INJURED.

    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 19834

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other VALLEY LAB GENERATOR (3/13/1998 TO 3/13/1998| (STOPPED)).