BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT

    MDR report key: 2971660 · Received February 10, 2013

    Report

    Report Number
    2971660
    Event Type
    Malfunction
    Date Received
    February 10, 2013
    Date of Event
    December 12, 2012
    Report Date
    February 8, 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

    THE TEFLON TIP ON THE THUNDERBEAT MELTED. ALL PIECES WERE ACCOUNTED FOR AND NO HARM WAS CAUSED TO THE PATIENT. THE HANDPIECE WAS REPLACED ON THE FIELD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC LIVER RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57884 THUNDERBEAT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI OLYMPUS AMERICA, INC TB-0535PC 2JA035

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR