BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP

    MDR report key: 3811132 · Received March 24, 2014

    Report

    Report Number
    2951238-2014-00127
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 28, 2014
    Report Date
    February 28, 2014
    Manufacturer
    OLYMPUS MED SYSTEM CORP
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A PANCREATECTOMY PROCEDURE. THE TEFLON PAD BURNED OUT. IT WAS NOTED THAT THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172520 THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MED SYSTEM CORP TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 TB-0535FC, LOT # UNK (2951238-2014-00126)