BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 3843056 · Received March 14, 2014

    Report

    Report Number
    2951238-2014-00104
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    January 28, 2014
    Report Date
    February 27, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THAT THE TEFLON PAD WAS DAMAGED. THE TEFLON PAD WAS INSPECTED AND FOUND A PARTIAL SEPARATION FROM THE GRASPING SECTION (JAW). THE TEFLON DAMAGE COULD OCCUR IF THE SEAL AND CUT OUTPUT WAS CONTINUOUSLY ACTIVATED WITHOUT ANY TISSUE IN THE GRASPING SECTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (LAVH) PROCEDURE, THE TEFLON PAD WAS PREMATURELY WORN OUT (PARTIALLY DETACHED) ON THE THUNDERBEAT HAND PIECE. NO OTHER INFO WAS PROVIDED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFO AND WAS INFORMED THAT DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE SEAL AND CUT BOTTOM TO TRANSECT THE TUBE AND OVARY WHEN THE TEFLON PAD BECAME WORN OUT (PARTIALLY DETACHED). A SECOND THUNDERBEAT HANDPIECE WAS USED AND THE TEFLON PAD OF THE SECOND HAND PIECE ALSO WORN OUT PREMATURELY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154558 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORP TB-0535FC K3820

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR TB-0535FC, SN # UNK (2951238-2014-000103)