BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CAUTERY

    MDR report key: 3181363 · Received June 3, 2013

    Report

    Report Number
    3181363
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    CODMAN & SHURTLEFF INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DURING A LAP CHOLECYSTECTOMY, THE SURGEON NOTED THAT THE MONOPOLAR CAUTERY SUDDENLY STOPPED WORKING. SURGEON NOTICED THAT THE MONOPOLAR CABLE BROKE INTO TWO PIECES AND NOTED A SMALL FIRE AT THE OF THE BROKEN PIECE. NO HARM TO PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC CHOLECYSTECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243914 MONOPOLAR CAUTERY ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CODMAN & SHURTLEFF INC. 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR