BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT

    MDR report key: 3010458 · Received March 16, 2013

    Report

    Report Number
    3010458
    Event Type
    Malfunction
    Date Received
    March 16, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 11, 2013
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THUNDERBEAT GENERATOR DISPLAYED AN ERROR MESSAGE IN THE MIDDLE OF THE CASE. THE DEVICE HAD BEEN WORKING AS NORMAL, THEN ALL OF A SUDDEN, THE HANDPIECE STARTED MAKING A "LOUD SCREECHING" NOISE. THEN THE GENERATOR DISPLAYED AN ERROR, SUCH AS "PROBE DAMAGE," OR "PROBE FAILURE." THE TIPS LOOKED FINE. THERE WAS NO NEED TO CLEAN THEM. AND THE SURGEONS WERE NOT WORKING CLOSE TO A STAPLE LINE, AS THEY HADN'T STARTED STAPLING YET. SURGEON MENTIONED THAT THEY WERE WORKING ON "THINNER" TISSUE. A NEW HANDPIECE WAS INTRODUCED AND WORKED WITHOUT ERROR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC SLEEVE GASTRECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111076 THUNDERBEAT INSTRUMENT, ELECTROSURGICAL/ULTRASONIC GEI OLYMPUS AMERICA, INC. * 2JA035

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR