BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT OPEN EXTENDED JAW

    MDR report key: 5170952 · Received October 23, 2015

    Report

    Report Number
    8010047-2015-01014
    Event Type
    Malfunction
    Date Received
    October 23, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 1, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K132703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE WAS DISCARDED BY THE USER, THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), THEREFORE OMSC COULD NOT EVALUATE THE REFERENCED DEVICE. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THE EXACT CAUSE OF THIS ISSUE CANNOT BE CONCLUSIVELY DETERMINED. BASED ON THE PAST SIMILAR CASES 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 AND 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 A LAPAROSCOPIC SIGMOIDECTOMY. THE PROBE OF THE DEVICE WAS BROKEN OFF AND THE PROBE FRAGMENT FELL OFF INSIDE THE PATIENT. THE PROBE FRAGMENT WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER THUNDERBEAT DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701547 THUNDERBEAT OPEN EXTENDED JAW THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0920OE 53K

    Patients

    Seq Age Sex Outcome Treatment
    1