BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 3862171 · Received April 1, 2014

    Report

    Report Number
    2951238-2014-00160
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    LFL
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION BY OLYMPUS. THE EVALUATION CONFIRMED THE USER'S REPORTED PHENOMENON OF A DAMAGED PROBE. 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.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THERE WERE TECHNICAL ISSUES WHICH INCLUDED ULTRASONIC LEVEL ERRORS AND PROBE DAMAGE ERRORS. THIS REPORT IS IN REFERENCE TO THE SECOND OF THE TWO THUNDERBEATS THAT FAILED DURING THE PROCEDURE, DUE TO FAILED PROBE CHECKS ERROR MESSAGES. THE DEVICE WAS EXCHANGED FOR A THIRD THUNDERBEAT. THE INTENDED PROCEDURE WAS UNSUCCESSFULLY COMPLETED WITH THE FOURTH THUNDERBEAT DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194746 THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE LFL OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC K3Z24

    Patients

    Seq Age Sex Outcome Treatment
    1 TB-0535FC, LOT # K3Z04, MFR #2951238-2014-00128| TB-0535FC, LOT # K3Z04, MFR #2951238-2014-00150