BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP

    MDR report key: 5927917 · Received September 5, 2016

    Report

    Report Number
    8010047-2016-01122
    Event Type
    Malfunction
    Date Received
    September 5, 2016
    Date of Event
    March 17, 2015
    Report Date
    September 6, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT 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 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. AND THERE WAS A POSSIBILITY THAT PROBE DAMAGE ERROR OCCURRED SINCE PROBE WAS CRACKED BY ANY OF THE ABOVE REASON. 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 HYSTERECTOMY. THE PROBE OF THE DEVICE FELL OFF INSIDE THE PATIENT. THE FRAGMENT OF THE PROBE WAS RETRIEVED FROM THE PATIENT. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579499 THUNDERBEAT 5MM 35CM FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC 53K

    Patients

    Seq Age Sex Outcome Treatment
    1