BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 12304937 · Received August 10, 2021

    Report

    Report Number
    8010047-2021-10041
    Event Type
    Injury
    Date Received
    August 10, 2021
    Report Date
    August 11, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. SINCE THE SERIAL NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. HOWEVER, OMSC HAS ONLY SHIPPED DEVICES THAT PASSED THE INSPECTION. IN THE LITERATURE, THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "MINIMAL-INVASIVE VERSUS OPEN HEPATECTOMY FOR COLORECTAL LIVER METASTASES: BICENTRIC ANALYSIS OF POSTOPERATIVE OUTCOMES AND LONG-TERM SURVIVAL USING PROPENSITY SCORE MATCHING ANALYSIS". THE LITERATURE REPORTED THE RESULT OF 320 PATIENTS WITH COLORECTAL LIVER METASTASES (CRLM) WHO UNDERWENT PALLIATIVE ENDOBILIARY RADIOFREQUENCY ABLATION PROCEDURE USING THE OLYMPUS THUNDERBEAT AND NON-OLYMPUS DEVICE FROM JANUARY 2016 TO NOVEMBER 2018. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AS FOLLOWS; 90-DAY COMPLICATIONS/POSTOPERATIVE MORBIDITY (16 CASES). 90-DAY MAJOR COMPLICATIONS (12 CASES). 90-DAY MORTALITY (1 CASE). DEATH INCLUDING INTRAHEPATIC RECURRENCE (5 CASES). INTRAOPERATIVE BLOOD LOSS REQUIRED TRANSFUSION (8 CASES). POSTOPERATIVE CHEMOTHERAPY (22 CASES). POSTOPERATIVE ICU STAY (57 CASES). THERE ARE NOT MENTIONED THAT THESE COMPLICATIONS WERE RELATED TO THE SUBJECT DEVICE IN QUESTION. HOWEVER, OMSC ASSUMES THAT "INTRAOPERATIVE BLOOD LOSS REQUIRED TRANSFUSION" MIGHT BE RELATED TO " THUNDERBEAT" DUE TO THE PROCEDURE USING " THUNDERBEAT". OMSC ASSUMES THAT THE "INTRAOPERATIVE BLOOD LOSS REQUIRED TRANSFUSION" WAS SERIOUS INJURY DUE TO REQUIRED TRANSFUSION. THEREFORE, OMSC ASSUMES THAT "INTRAOPERATIVE BLOOD LOSS REQUIRED TRANSFUSION" WAS MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. THEREFORE, OMSC ASSUMES THAT THE "INTRAOPERATIVE BLOOD LOSS REQUIRED TRANSFUSION" WAS ADVERSE EVENTS TO SUBMIT. OMSC WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) OF THE SUBJECT DEVICE FOR THE "INTRAOPERATIVE BLOOD LOSS REQUIRED TRANSFUSION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198230 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention