BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 3760949 · Received April 9, 2014

    Report

    Report Number
    8010047-2014-00127
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 7, 2014
    Report Date
    March 11, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVALUATION BECAUSE THE FACILITY DISCARDED THE REFERENCED DEVICE, THEREFORE OMSC COULD NOT EVALUATE THE REFERENCED DEVICE. THE EXACT CAUSE OF THIS ISSUE CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, DEPENDING ON THE CONDITION OF THE PATIENT AND/OR TISSUE, USAGE, IT IS KNOWN THAT THE PROCEDURE MAY FAIL TO THE SECURE SEAL OF THE BLOOD VESSEL. THEREFORE, IN THIS CASE, THERE WAS A POSSIBILITY THAT THE PATIENT HAD BLED BECAUSE THE BLOOD VESSEL WAS NOT SEALED SECURELY DEPENDING ON THE PATIENT'S CONDITION AND/OR THE USER'S USAGE. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO THE PATIENT'S CONDITION AND/OR USER HANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING THE LAPAROSCOPIC GASTRECTOMY FOR THE PATIENT WITH SEVERE LYMPH-NODE METASTASIS, THE PHYSICIAN HAD PERFORMED THE REMOVAL OF THE LYMPH NODES AND ALSO SEAL AND CUT FOR THE SPLENIC ARTERY WITH THE USE OF THE TB-0535FC. THE PHYSICIAN HAD CONFIRMED THAT THERE HAD BEEN NO BLEEDING VESSEL, THEN CLOSED THE INCISION AND COMPLETED THE PROCEDURE. ON THE SAME DAY LATE-EVENING, THE PATIENT HAD VOMITED BLOOD. NEXT DAY, THE PHYSICIAN HAD ARRESTED HEMORRHAGE BY LAPAROSCOPIC SURGERY, AFTER THAT THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213273 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP THUNDERBEAT HANDPIECE GEI OLYMPUS MEDICAL SYSTEMS CORPORATION TB-0535FC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1