BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT ACUATED

    MDR report key: 3896047 · Received May 20, 2014

    Report

    Report Number
    2951238-2014-00173
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0342-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE TELFON PAD WAS FOUND MELTED AND PARTIALLY LIFTED FROM THE GRASPING SECTION. THIS TYPE OF TEFLON PAD DAMAGE CAN RESULT FROM CONTINUOUS ACTIVATION OF THE JAW OUTPUT WITHOUT TISSUE BETWEEN THE PROBE AND JAW. THE SUBJECT DEVICE WAS TESTED USING AN ESG-400/USG-400 AND NO PROBLEM WAS FOUND.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE THUNDERBEAT HANDPIECE STOPPED WORKING. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORT BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299552 OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT ACUATED ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC K4217

    Patients

    Seq Age Sex Outcome Treatment
    1