BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KARL STORZ

    MDR report key: 21131 · Received July 29, 1994

    Report

    Report Number
    21131
    Event Type
    Malfunction
    Date Received
    July 29, 1994
    Date of Event
    June 7, 1994
    Report Date
    June 15, 1994
    Manufacturer
    KARL STORZ ENDOSCOPY/AMERICA, INC.
    Product Code
    HQR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON ENGAGED BOVIE FOOT PEDAL FOR COAGULATION AND RECEIVED A SLIGHT ELECTRIC SHOCK TO HAND. APPROXIMATELY 3-4 INCHES OF THE RUBBER COATING ON THE DISSECTING INSTRUMENT SPLIT AND MELTED AWAY FROM METAL INSTURMENT. THIS WAS NOTICED UPON REMOVING THE DISSECTING INSTRUMENT FROM THE PORT USED DURING A LAPAROSCOPIC CHOLEYSTECTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ CAUTERY KNIFE HQR KARL STORZ ENDOSCOPY/AMERICA, INC. 28175 UE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other