BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND-HELD HOOK TIP COAGULATOR

    MDR report key: 171455 · Received June 5, 1998

    Report

    Report Number
    1825883-1998-00007
    Event Type
    Malfunction
    Date Received
    June 5, 1998
    Date of Event
    May 4, 1998
    Report Date
    May 4, 1998
    Manufacturer
    INSTRUMENT MAKAR, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ELECTROCAUTERY UNIT WAS BEING USED FOR ARTHROSCOPIC CAUTERY OF THE SHOULDER. THE CAUTERY UNIT BUTTON APPEARED TO STICK IN THE ON POSITION AND WOULD NOT SHUT OFF. THE PT WAS NOT AFFECTED.

    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 21160

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other