BEUDAMED
    FDA Adverse Event Death Summary report: N

    THUNDERBEAT 5MM, 35CM FRONT ACTUATED GRIP

    MDR report key: 4192696 · Received October 8, 2014

    Report

    Report Number
    8010047-2014-00572
    Event Type
    Death
    Date Received
    October 8, 2014
    Report Date
    September 16, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE WAS DISCARDED BY THE USER FACILITY, THEREFORE OLYMPUS MEDICAL SYSTEM CORP (OMSC) COULD NOT EVALUATE THE REFERENCED DEVICE. THE EXACT CAUSE OF THIS ISSUE CANNOT BE CONCLUSIVELY DETERMINED. THIS DEVICE IS SUBJECT TO TOTAL INSPECTION TO ENSURE THAT THE DEVICE IS CAPABLE OF PROPERLY ACTIVATING OUTPUT BEFORE SHIPMENT BY OMSC. IF ADDITIONAL INFO IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    IN (B)(6) 2014, THE SUBJECT DEVICE WAS USED DURING A PROCEDURE OF THE ESOPHAGEAL CANCER. THE PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. THERE WAS NO ACCIDENT ABOUT THE DEVICE AND THE PROCEDURE. HOWEVER, 4 DAYS AFTER THE PROCEDURE, THE PT HAS DIED. OLYMPUS HAS FOLLOWED UP WITH USER FACILITY TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT, BUT WITH ON RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633052 THUNDERBEAT 5MM, 35CM FRONT ACTUATED GRIP THUNDERBEAT HANDPIECE LFL OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death