BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 10599575 · Received September 29, 2020

    Report

    Report Number
    10599575
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 14, 2020
    Report Date
    September 15, 2020
    Manufacturer
    OLYMPUS SURGICAL TECHNOLOGIES AMERICA
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A HYSTERECTOMY THE LAPAROSCOPIC THUNDERBEAT THIN LINE OF PLASTIC INSIDE OF THE CAUTERY END BECAME FIRED AND DEBILITATED THE HAND PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062744 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI OLYMPUS SURGICAL TECHNOLOGIES AMERICA TB-0535FC KR10805

    Patients

    Seq Age Sex Outcome Treatment
    1 14600 DA