BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 17188046 · Received June 22, 2023

    Report

    Report Number
    9614641-2023-00895
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    February 2, 2023
    Report Date
    July 6, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383540
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 - HEALTH EFFECT - CLINICAL CODE 4581 IS USED FOR POSTOPERATIVE ILEUS. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION COULD BE PROVIDED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED, "COMPARISON OF PERIOPERATIVE OUTCOMES BETWEEN BIPOLAR SEALING, ULTRASONIC SHEARS AND A HYBRID DEVICE DURING LAPAROSCOPIC GASTRECTOMY FOR EARLY GASTRIC CANCER:A PROSPECTIVE,MULTICENTER,RANDOMIZED STUDY." LITERATURE SUMMARY BACKGROUND ALTHOUGH EBDS ARE ESSENTIAL FOR MINIMALLY INVASIVE SURGERY, WELL-ESTABLISHED PROSPECTIVE RANDOMIZED STUDIES COMPARING EBDS ARE SCARCE. THIS STUDY AIMED TO COMPARE THE INTRAOPERATIVE INFLAMMATORY RESPONSE AND SHORT-TERM SURGICAL OUTCOMES AMONG DIFFERENT ENERGY-BASED DEVICES (EBDS) IN LAPAROSCOPIC DISTAL GASTRECTOMY (LDG). METHODS PATIENTS WITH CLINICAL STAGE I GASTRIC CANCER SCHEDULED FOR LDG AT TWO DIFFERENT MEDICAL CENTERS WERE PROSPECTIVELY RANDOMIZED INTO THREE GROUPS: ULTRASONIC SHEARS (US), ADVANCED BIPOLAR (BP) AND ULTRASONIC-BIPOLAR HYBRID (HB). THE C-REACTIVE PROTEIN (CRP) LEVEL, OPERATION TIME, INTRAOPERATIVE BLOOD LOSS (IBL), LABORATORY TESTS, CYTOKINES (INTERLEUKIN (IL)-6 AND IL-10), HOSPITAL STAY, AND COMPLICATION RATE WERE ANALYZED. A NOVEL SEMIQUANTITATIVE MEASUREMENT METHOD USING INDOCYANINE GREEN (ICG) AND A NEAR-INFRARED CAMERA MEASURED THE AMOUNT OF LYMPHATIC LEAKAGE. RESULTS THE PRIMARY ENDPOINT, THE CRP LEVEL, WAS SIGNIFICANTLY LOWER IN THE BP (N¿=¿60) GROUP THAN IN THE US (N=57) OR HB (N=57) GROUP [9.03±5.55 VS. 11.12±5.02 VS. 12.67±6.14, P=0.001, ON POSTOPERATIVE DAY (POD) 2 AND 7.48 VS. 9.62 VS. 9.48, P=0.026, ON POD 4]. IBL WAS SIGNIFICANTLY LOWER IN BP THAN IN US OR HB (26.3±25.3 VS. 43.7±42.0 VS. 34.9±37.0, P=0.032). JACKSON¿PRATT DRAINAGE TRIGLYCERIDES WERE SIGNIFICANTLY LOWER IN BP THAN IN US (53.6±33.7 VS. 84.2±59.0, P=0.11; HB: 71.3±51.4). ICG FLUORESCENCE INTENSITY, OPERATION TIME, LABORATORY RESULTS, CYTOKINES, HOSPITAL STAY, AND COMPLICATION RATE WERE NOT SIGNIFICANTLY DIFFERENT AMONG THE 3 GROUPS. CONCLUSION BP SHOWED A LOWER POSTOPERATIVE CRP LEVEL AND LESS IBL THAN US AND HB, SUGGESTING LESS COLLATERAL THERMAL DAMAGE AND BETTER SEALING FUNCTION. SURGEONS MAY CONSIDER THIS WHEN SELECTING EBDS FOR LAPAROSCOPIC SURGERY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS *ANASTOMOSIS SITE STENOSIS -3 *POSTOPERATIVE ILEUS -1 THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001397 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS UNKNOWN(LITERATURE) 04953170383540

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other