BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT

    MDR report key: 3120007 · Received May 10, 2013

    Report

    Report Number
    3120007
    Event Type
    Malfunction
    Date Received
    May 10, 2013
    Date of Event
    April 6, 2013
    Report Date
    May 10, 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

    THUNDERBEAT INSTRUMENT DEFAULTED. SIGN ON MACHINE SAID "DAMAGED ERROR." HANDPIECE WAS IMMEDIATELY REPLACED, SETTING RESUMED TO 1 CUT 2 SEAL.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPY WITH RIGHT PARATUBAL CYSTECTOMY AND RIGHT OOPHORECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205397 THUNDERBEAT ELECTROSURGICAL, ACCESSORY, HANDPIECE GEI OLYMPUS AMERICA, INC, TB0535PC 2JA076

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR