BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIPU1

    MDR report key: 3862153 · Received April 1, 2014

    Report

    Report Number
    2951238-2014-00161
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 ERROR MESSAGE TO REPLACE THE 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. THE PROXIMAL END OF THE DEVICE WAS INSPECTED UNDER MICROSCOPE AND THE PROBE WAS FRACTURED. THIS TYPE OF TEFLON PAD 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 A TOTAL LAPAROSCOPIC HYSTERECTOMY, THERE WERE TECHNICAL ISSUES WHICH INCLUDED ULTRASONIC LEVEL ERROR AND PROBE DAMAGE ERROR. THIS REPORT IS IN REFERENCE TO THE THIRD OF THE THREE THUNDERBEATS THAT FAILED DURING THE PROCEDURE DUE TO FAILED PROBE CHECKS ERROR MESSAGES. IT WAS NOTED THAT THE PROBE BROKE AND THE BROKEN MATERIAL WAS RETRIEVED WITHOUT ANY PATIENT ISSUE. THE DEVICE WAS EXCHANGED FOR A FOURTH THUNDERBEAT. THE INTENDED PROCEDURE WAS UNSUCCESSFULLY COMPLETED WITH THE DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196231 THUNDERBEAT 5MM, 35 CM, FRONT-ACTUATED GRIPU1 ULTRASONIC SURGICAL DEVICE LFL OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC K3Z04

    Patients

    Seq Age Sex Outcome Treatment
    1 TB-0535FC, LOT # K3Z24, MFR: 2951238-2014-00148| TB-0535FC, LOT # K3Z04, MFR: 2951238-2014-00128