BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUR THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED

    MDR report key: 3905254 · Received May 28, 2014

    Report

    Report Number
    2951238-2014-00236
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Report Date
    May 12, 2014
    Manufacturer
    OLYMPUS MED SYSTEMS CORP
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Removal / Correction Number
    Z-0342-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    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 AN UNSPECIFIED PROCEDURE, THE PROBE TIP ON THE HANDPIECE BROKE OFF. THE BROKEN TIP WAS FOUND ON THE FLOOR. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY TO OBTAIN ADD'L INFO BUT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314875 OLYMPUR THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATED ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MED SYSTEMS CORP TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1