BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT

    MDR report key: 3130943 · Received May 11, 2013

    Report

    Report Number
    3130943
    Event Type
    Malfunction
    Date Received
    May 11, 2013
    Date of Event
    March 20, 2013
    Report Date
    May 7, 2013
    Manufacturer
    OLYMPUS AMERICA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SURGEON USING THUNDERBEAT INSTRUMENT AND A PIECE OF THE JAW BROKE. NOTICED AND REMOVED INSTRUMENT, PIECE OF JAW FELL INTO ABDOMEN. PIECE RETRIEVED AND REMOVED. ALL PIECES OUT OF THE PATIENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY AND CYSTOSCOPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209830 THUNDERBEAT ELECTROSURGICAL, ACCESSORY, HANDPIECE GEI OLYMPUS AMERICA, INC. TB-0535PC 28K

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR