BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12346175 · Received August 19, 2021

    Report

    Report Number
    8010047-2021-10505
    Event Type
    Injury
    Date Received
    August 19, 2021
    Report Date
    August 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170383557
    PMA / PMN Number
    K172610
    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

    ON AUGUST 2, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "PROGNOSTIC EVALUATION OF HCC PATIENTS UNDERGOING SURGICAL RESECTION: AN ANALYSIS OF 8 DIFFERENT STAGING SYSTEMS". THE PURPOSE OF THIS LITERATURE WAS TO EVALUATE THE PROGNOSTIC ABILITY OF EACH STAGING SYSTEM TO DETERMINE THE ¿BEST¿ PERFORMING MODEL IN A EUROPEAN COHORT OF PATIENTS UNDERGOING CURATIVE-INTENT SURGERY FOR HEPATOCELLULAR CARCINOMA (HCC). IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; THE STUDY COMPRISED 160 CONSECUTIVE HCC PATIENTS WHO UNDERWENT CURATIVE-INTEND SURGERY AT THE UNIVERSITY HOSPITAL RWTH AACHEN BETWEEN 2010 AND 2019. A TOTAL OF 160 PATIENTS WITH A MEDIAN AGE OF 68 YEARS AND A MEDIAN BMI OF 26 KG/M2 WERE INCLUDED. IN LAPAROSCOPIC HEPATECTOMY, PARENCHYMAL TRANSECTION WAS COMMONLY PERFORMED BY THUNDERBEAT (SUBJECT DEVICE), HARMONIC ACE (ETHICON), OR LAPAROSCOPIC CUSA (INTEGRA LIFESCIENCES) IN COMBINATION WITH VASCULAR STAPLERS (ECHELON, ETHICON) OR POLYMER CLIPS (TELEFLEX). FOLLOWS COMPLICATIONS WERE REPORTED. INTRAOPERATIVE BLOOD TRANSFUSION (49). INTRAOPERATIVE FRESH FROZEN PLASMA (69). INTRAOPERATIVE PLATELET TRANSFUSION (4). POSTOPERATIVE COMPLICATIONS / CLAVIEN-DINDO I (20), II (19). POSTOPERATIVE COMPLICATIONS / CLAVIEN-DINDO IIIA (18), IIIB (9), IVA (7), IVB (2), V (10). BASED ON THE AVAILABLE INFORMATION, REPORTED PERFORATION WAS NOT REPORTED IN A DIRECT RELATIONSHIP WITH THE SUBJECT DEVICE. OMSC ASSUMES THAT POSTOPERATIVE COMPLICATIONS WERE NOT RELATED TO THE SUBJECT DEVICE. HOWEVER, INTRAOPERATIVE BLOOD TRANSFUSION, INTRAOPERATIVE FRESH FROZEN PLASMA, AND INTRAOPERATIVE PLATELET TRANSFUSION WERE MIGHT BE RELATED TO THE SUBJECT DEVICE DUE TO USING AT PARENCHYMAL TRANSECTION WITH THE SUBJECT DEVICE. WHEREAS, OMSC ASSUMES THAT INTRAOPERATIVE BLOOD TRANSFUSION, INTRAOPERATIVE FRESH FROZEN PLASMA, AND INTRAOPERATIVE PLATELET TRANSFUSION MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THEREFORE, OMSC ASSUMES THAT THESE INTEROPERATIVE COMPLICATIONS WERE AN ADVERSE EVENT TO SUBMIT. 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 WILL SUBMIT A MEDICAL DEVICE REPORT (MDR) OF THE SUBJECT DEVICE FOR THE INTEROPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243013 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS 04953170383557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other