BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-HELD HOOK TIP COAGULATOR

    MDR report key: 156614 · Received March 13, 1998

    Report

    Report Number
    1825883-1998-00004
    Event Type
    Malfunction
    Date Received
    March 13, 1998
    Date of Event
    February 13, 1998
    Report Date
    February 16, 1998
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE #1: AFTER HAVING BEEN USED AND SET ASIDE TEMPORARILY, THE ELECTROCAUTERY PEN WAS RETURNED INTO THE PT SHOULDER. THE ELECTROCAUTERY PEN SPONTANEOUSLY ACTIVATED WITHOUT THE BUTTONS BEING TOUCHED. THE ELECTROCAUTERY PEN WAS REMOVED FROM THE SHOULDER AND UNPLUGGED. THE PT WAS NOT AFFECTED. DEVICE #2: A SECOND ELECTROCAUTERY PEN WAS OPENED AND PLUGGED INTO THE GENERATOR WHERE IT SPONTANEOUSLY ACTIVATED BEFORE IT COULD BE USED. THE PT WAS NOT INVOLVED.

    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 (02/13/1998 TO 02/13/1998)| ASPEN EXCALIBUR GENERATOR, MODEL 605200-001