BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 3851870 · Received April 12, 2014

    Report

    Report Number
    2951238-2013-00190
    Event Type
    Malfunction
    Date Received
    April 12, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 19, 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
    ND, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCE IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION NOTED THAT THE TEFLON PAD WAS PARTIALLY SPLIT AND TORN IN THE MIDDLE OF THE GRASPING SECTION. THIS TYPE OF DAMAGE CAN RESULT FROM CONTINUOUS ACTIVATION OF THE OUTPUT WITHOUT TISSUE BETWEEN THE PROBE AND THE GRASPING SECTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE FAILED TO OPERATE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226316 THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC K3Z05

    Patients

    Seq Age Sex Outcome Treatment
    1