BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12888464 · Received November 29, 2021

    Report

    Report Number
    8010047-2021-15216
    Event Type
    Injury
    Date Received
    November 29, 2021
    Report Date
    November 30, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170383557
    PMA / PMN Number
    K211838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    ON (B)(6) 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "OUTCOMES AFTER 3D LAPAROSCOPIC AND ROBOTIC LIVER RESECTION FOR HEPATOCELLULAR CARCINOMA: A MULTICENTER COMPARATIVE STUDY". IN THIS STUDY, FROM 2011 TO 2017, 93 PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC), INCLUDING 58 WITH CIRRHOSIS, UNDERWENT 3D-LAPAROSCOPIC LIVER RESECTION (3D-LLR) (49 PATIENTS) OR ROBOTIC LIVER RESECTION (RLR) (44 PATIENTS), RESPECTIVELY. FOR THE 3D-LLR, A 3D FLEXIBLE LAPAROSCOPE AND A THUNDERBEAT SCALPEL WERE USED. FOR THE PROCEDURE, THE MEDIAN AGE OF THE PATIENTS WAS 65 ± 12 YEARS, AND 40 PATIENTS WERE MEN. IN THE LITERATURE FOR THE PROCEDURE, IT WAS REPORTED THAT THE FOLLOWING. *BLOOD TRANSFUSION AND CONVERSION TO OPEN APPROACH OCCURRED INTRAOPERATIVELY IN 1 AND 7 PATIENTS, RESPECTIVELY. *AS POSTOPERATIVE OUTCOMES, 90-DAY OVERALL MORBIDITY, 90-DAY SEVERE MORBIDITY, INFECTIOUS COMPLICATIONS, AND SURGICAL COMPLICATIONS WERE REPORTED IN 13, 2, 4, AND 4 PATIENTS, RESPECTIVELY. SURGICAL COMPLICATIONS INCLUDED ONE EACH OF LIVER FAILURE, BILIARY COMPLICATIONS, ASCITES, AND DELAYED GASTRIC EMPTYING. *ALL COMPLICATIONS WERE ASSESSED FOR UP TO 90 DAYS AFTER SURGERY. BASED ON THE AVAILABLE INFORMATION, REPORTED BLOOD TRANSFUSION, CONVERSION TO OPEN APPROACH, 90-DAY MORBIDITY, INFECTIOUS COMPLICATIONS, AND SURGICAL COMPLICATIONS WERE NOT REPORTED IN A DIRECT RELATIONSHIP WITH THE OLYMPUS PRODUCTS. HOWEVER, OMSC ASSUMES THAT THE BLOOD TRANSFUSION, THE CONVERSION TO OPEN APPROACH, AND THE 90-DAY SEVERE MORBIDITY MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR THE PROCEDURE. AND, OMSC ASSUMES THAT THE BLOOD TRANSFUSION, THE CONVERSION TO OPEN APPROACH, AND THE 90-DAY SEVERE MORBIDITY MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. OMSC ASSUMES THAT THE 90-DAY MORBIDITY(EXCEPT FOR SEVERE), THE INFECTIOUS COMPLICATIONS, AND THE SURGICAL COMPLICATIONS WERE NOT SERIOUS SINCE 90-DAY SEVERE MORBIDITY AS THE POSTOPERATIVE OUTCOME WAS REPORTED IN 2 PATIENTS. THEREFORE, OMSC ASSUMES THAT THE BLOOD TRANSFUSION, THE CONVERSION TO OPEN APPROACH, AND THE 90-DAY SEVERE MORBIDITY WERE ADVERSE EVENTS TO SUBMIT. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENT (EXCEPT FOR SOME, FOR EXAMPLE, AGE) WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT ONE MEDICAL DEVICE REPORT (MDR) OF THE SUBJECT DEVICE FOR THE BLOOD TRANSFUSION, THE CONVERSION TO OPEN APPROACH, AND THE 90-DAY SEVERE MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778462 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 Unknown Required Intervention