BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK TIP HAND CONTROLLED COAGULATOR

    MDR report key: 46418 · Received September 16, 1996

    Report

    Report Number
    1825883-1996-00005
    Event Type
    Malfunction
    Date Received
    September 16, 1996
    Date of Event
    August 9, 1996
    Report Date
    September 13, 1996
    Manufacturer
    INSTUMENT 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

    HOOK TIP HAND CONTROLLED COAGULATOR MALFUNCTIONED DURING USE. THE "CUT" STAYED ON EVEN WHEN THE BUTTON WAS NOT BEING DEPRESSED. A FLAME WAS SEEN AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOOK TIP HAND CONTROLLED COAGULATOR COAGULATOR GEI INSTUMENT MAKAR, INC. 10798 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other