BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 12716578 · Received October 28, 2021

    Report

    Report Number
    8010047-2021-13787
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 16, 2021
    Report Date
    November 8, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OMSC FOR EVALUATION. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO WITHDRAW MFR REPORT #8010047-2021-13787. ON OCTOBER 29, OLYMPUS MEDICAL SYSTEMS CORP. WAS INFORMED FROM OLYMPUS CHINA AS BELLOW. "THIS COMPLAINT WAS CREATED MANUALLY EARLIER BECAUSE THE FUNCTION OF " SENDING IT TO QIS AUTOMATICALLY " WAS NOT WORKING IN SFDC SYSTEM. THEREFORE, IT IS A REPEATED CASE OF (B)(4)AND IT'S UNNECESSARY TO REPORT AGAIN." OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THAT THERE WAS NO MDR REPORTABLE MALFUNCTION OR ADVERSE EVENT.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING A RADICAL BLADDER CANCER SURGERY LYMPH NODE DISSECTION USING THE SUBJECT DEVICE, U504 ERROR OCCURRED. THE PROBE WAS BROKEN OFF. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THERE WAS NO CUTTING HARD TISSUES OR TOUCHING METAL CLAMPS WITH THE SUBJECT DEVICE DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611539 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC 12K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown