BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-HELD HOOK TIP COAGULATOR

    MDR report key: 154014 · Received February 27, 1998

    Report

    Report Number
    1825883-1998-00003
    Event Type
    Malfunction
    Date Received
    February 27, 1998
    Date of Event
    January 29, 1998
    Report Date
    February 27, 1998
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BUTTON SWITCH ON ELECTROCAUTERY PEN FAILED TO REACT TO RELEASE OF CUT BUTTON, AND PEN STAYED ACTIVATED. 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