BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK TIP TIP ONLY COAGULATOR

    MDR report key: 51576 · Received November 18, 1996

    Report

    Report Number
    1825883-1996-00006
    Event Type
    Malfunction
    Date Received
    November 18, 1996
    Date of Event
    September 20, 1996
    Report Date
    October 16, 1996
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS PERFORMING A LATERAL RELEASE USING CO'S COAGULATOR IN A CONDUCIVE MEDIUM WITH COAGULATOR SET AT 50. A SMALL PORTION OF THE COAGULATOR BROKE OFF IN THE JOINT. THE SURGEON COULD NOT RETRIEVE THE BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOOK TIP TIP ONLY COAGULATOR COAGULATOR GEI INSTRUMENT MAKAR, INC. #10782 #008513

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN