BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP

    MDR report key: 3853247 · Received April 3, 2014

    Report

    Report Number
    2951238-2014-00145
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    December 14, 2013
    Report Date
    March 20, 2014
    Manufacturer
    OLYMPUS MEDICAL SYS CORP
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THE USERS REPORTED PHENOMENON OF A DAMAGED PROBE. THE DEVICE WAS ATTACHED TO OLYMPUS TEST EQUIPMENT. A PROBE CHECK WAS PERFORMED ON THE DEVICE AND THE PROBE CHECK FAILED. AN ERROR CODE U509 WAS OBSERVED. BOTH OF THE SWITCHES WERE CHECKED AND BOTH FAILED TESTING. A VISUAL INSPECTION NOTED THAT THE TEFLON PAD WAS FOUND TO HAVE NORMAL WEAR. THE PROXIMAL END OF THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND THE PROBE WAS FOUND FRACTURED, AND THE MISSING PORTION WAS NOT RETURNED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT PRIOR TO AN UNSPECIFIED PROCEDURE THE SURGEON INSPECTED THE TIP OF THE THUNDERBEAT AND THE TIP WAS LOOSE AND FELL OFF. THE DEVICE WAS EXCHANGED FOR ANOTHER THUNDERBEAT DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203054 THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYS CORP TB-0535FC K3718

    Patients

    Seq Age Sex Outcome Treatment
    1