BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35CM, FRONT-ACUATED GRIP

    MDR report key: 3901706 · Received May 5, 2014

    Report

    Report Number
    2951238-2014-00187
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORP
    Product Code
    LFL
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE BROKE OFF. THE PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE AND THERE WAS NO PT INJURY REPORTED. NO OTHER INFO WAS PROVIDED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO REGARDING THE REPORT BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268033 THUNDERBEAT 5MM, 35CM, FRONT-ACUATED GRIP ILTRASONIC SURGICAL DEVICE LFL OLYMPUS MEDICAL SYSTEM CORP TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1