BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP

    MDR report key: 3896048 · Received May 20, 2014

    Report

    Report Number
    2951238-2014-00194
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 9, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0432-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORTED WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION COULD NOT CONFIRM THE USER'S REPORTED PHENOMENON OF A FAILED OR NON FUNCTIONING DEVICE. A PROBE CHECK WAS PERFORMED ON THE DEVICE AND NO ANOMALIES WERE FOUND AS BOTH SWITCHES WERE NORMAL. A VISUAL INSPECTION NOTED THAT THE TEFLON PAD WAS PARTIALLY SPLIT AND TORN AT THE DISTAL END. ADDITIONAL EVALUATION FOUND THE TEFLON PAD MISSING AND THE METAL JAW WAS EXPOSED. THE GRASPING SECTION OF THE DEVICE WAS FOUND CHARRED. THE PROXIMAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND FOUND NO VISUAL INDICATION OF DAMAGE TO THE PROBE UNIT. THIS TYPE OF TEFLON PAD DAMAGE CAN RESULT FROM CONTINOUS ACTIVATION OF THE OUTPUT WITHOUT TISSUE BETWEEN THE PROBE AND THE GRASPING SECTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE, SEVERAL ERROR MESSAGES WERE OBSERVED AND THE DEVICE STOP FUNCTIONING. THE CORD WAS REPLACED AND THE UNIT STILL DID NOT FUNCTION. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED WITHOUT ISSUE WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299165 THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC K3708

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR