BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT ACTUATED GRIP

    MDR report key: 4371118 · Received December 19, 2014

    Report

    Report Number
    8010047-2014-01137
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    July 23, 2014
    Report Date
    December 9, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE WAS DISCARDED BY THE USER FACILITY, THEREFORE OLYMPUS MEDICAL SYSTEMS CORP (OMSC) COULD NOT EVALUATE THE REFERENCED DEVICE. THIS DEVICE IS SUBJECT TO TOTAL INSPECTION TO ENSURE THAT THE DEVICE IS CAPABLE OR PROPERLY ACTIVATING OUTPUT BEFORE SHIPMENT BY OMSC. THE EXACT CAUSE OF THIS ISSUE CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE SIMILAR CASE WITH THE SAME MODEL, IT IS KNOWN THAT THE REPORTED EVENT OCCUR SINCE THE USER OUTPUTS THE DEVICE CONTACTING WITH SOMETHING HARD OR THE PROBE NAD THE JAW COME INTO CONTACT, WHICH CAUSES SCRATCHES BECAUSE OF WEAR OF THE PTFE PAD. THE INSTRUCTION MANUAL OF THUNDERBEAT MENTIONS WARNING AND CAUTION FOR POSSIBLE MISHANDLING MENTIONED ABOVE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING AN UNCERTAIN PROCEDURE. THE PROBE DAMAGE ERROR MESSAGE WAS DISPLAYED. SO, THE USER CLEANED THE PROBE TIP. AT THAT TIME, THE PROBE WAS BROKEN AND PROBE TIP FELL OFF OUTSIDE THE PT. THE PROCEDURE WAS CONTINUED WITH ANOTHER THUNDERBEAT DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837461 THUNDERBEAT 5MM 35CM FRONT ACTUATED GRIP THUNDERBEAT HANDPIECE LFL OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1