BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 15573195 · Received October 10, 2022

    Report

    Report Number
    9614641-2022-00441
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    March 17, 2022
    Report Date
    November 3, 2022
    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

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    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. THIS SUPPLEMENTAL REPORT INCLUDES INFORMATION ADDED TO B5 AND G2. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "OPERATIVE AND LONG-TERM ONCOLOGIC OUTCOMES OF LAPAROSCOPIC VERSUS OPEN MAJOR LIVER RESECTION IN PATIENTS WITH A HIGH BODY MASS INDEX (> 25 KG/M 2 ): A PROPENSITY SCORE MATCHING ANALYSIS." LITERATURE SUMMARY: THIS STUDY AIMED TO COMPARE THE SAFETY AND FEASIBILITY OF LAPAROSCOPIC MAJOR LIVER RESECTION (LMR) AND OPEN MAJOR LIVER RESECTION (OMR) IN PATIENTS WITH A HIGH BODY MASS INDEX. TOTAL 521 PATIENTS WERE INCLUDED IN THIS STUDY. ALTHOUGH THERE WAS NO SIGNIFICANT DIFFERENCE IN OVERALL COMPLICATIONS, NON-LIVER-SPECIFIC COMPLICATIONS WERE OBSERVED LESS FREQUENTLY AFTER LMR. THIS STUDY CONCLUDED THAT OBESITY SHOULD NOT BE CONSIDERED A CONTRAINDICATION FOR MAJOR LIVER RESECTION USING A LAPAROSCOPIC APPROACH; HOWEVER, WHEN APPLYING THIS APPROACH FOR RESECTING MALIGNANCIES IN PATIENTS WITH A BMI>30 KG/M2 AND COMORBID DISEASES, SPECIAL ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF COMPLICATIONS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: CLAVIEN¿DINDO GRADE I¿II 78. CLAVIEN¿DINDO GRADE IIIA 17. CLAVIEN¿DINDO GRADE IIIB 2. THE MODEL NO. OF THE PRODUCT (THUNDERBEAT) WAS UNKNOWN BUT A REPRESENTATIVE PRODUCT WAS CHOSEN FOR PROCESSING PURPOSES. (TB-0535FCS).

    Description of Event or Problem · 0

    THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: IT IS UNKNOWN IF AN OLYMPUS DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. THE LOT NUMBERS OF THE OLYMPUS DEVICES USED IN THE PROCEDURES DESCRIBED IN THE ARTICLE ARE UNKNOWN. IT IS ALSO UNKNOWN IF ANY OF THE DEVICES ARE AVAILABLE FOR RETURN TO OLYMPUS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288740 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 Required Intervention| O NON-OLYMPUS CAVITRON ULTRASONIC SURGICAL ASPIRATOR