BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 12619841 · Received October 12, 2021

    Report

    Report Number
    8010047-2021-13072
    Event Type
    Injury
    Date Received
    October 12, 2021
    Report Date
    October 13, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 SEPTEMBER 14, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "ANALYSIS OF ECONOMIC IMPACT OF LAPAROSCOPIC LIVER RESECTION ACCORDING TO SURGICAL DIFFICULTY". THE PURPOSE OF THIS LITERATURE WAS TO ANALYZE THE ECONOMIC IMPACT OF SURGICAL DIFFICULTY ON LAPAROSCOPIC LIVER RESECTION (LLR) COSTS BILLED TO THE HOSPITAL, AND TO IDENTIFY CLINICAL FACTORS THAT MOST AFFECT GLOBAL EXPENSES. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; THE STUDY COMPRISED ALL PATIENTS WHO UNDERWENT LLR AT INSTITUT MUTUALISTE MONTSOURIS WERE IDENTIFIED FROM JANUARY 2014 TO DECEMBER 2018. DATA WERE RETROSPECTIVELY RETRIEVED FROM A PROSPECTIVELY MAINTAINED DATABASE. THE DATA INCLUDED DEMOGRAPHIC VARIABLES, PRIMARY TUMOR CHARACTERISTICS AND MANAGEMENT, OPERATIVE DATA, TUMOR PATHOLOGY, SHORT-TERM OUTCOMES, AND ECONOMIC DATA. A TOTAL OF 270 PATIENTS WITH A MEDIAN AGE OF 64.9 YEARS WERE INCLUDED, AND THERE WERE 97 WOMEN AND 173 MEN. FOR ALL PROCEDURES, TISSUE DISSECTION AND HEMOSTASIS WERE PERFORMED BY ULTRASONIC DISSECTOR, MAINLY THE THUNDERBEAT (OLYMPUS) OR HARMONIC SCALPEL (ETHICON ENDO-SURGERY); THE GAYET BIPOLAR FORCEPS (MICROFRANCE CEVBG134; MEDTRONIC) PROVIDED RETRACTION AND RESCUE HEMOSTASIS. FOLLOWS COMPLICATIONS WERE REPORTED. -BLEEDING REQUIRED TRANSFUSION - (12) -ADMISSION IN ICU - (36) -RESPIRATORY FAILURE - (13) -LIVER FAILURE - (7) -ASCITES - (17) -BILIARY FISTULA - (16) -MINOR COMPLICATIONS - (57) -MAJOR COMPLICATIONS/CLAVIEN III - (26) -MAJOR COMPLICATIONS/CLAVIEN IV - (4) -MORTALITY - (2) OMSC ASSUMES THAT THE RESPIRATORY FAILURE, LIVER FAILURE, ASCITES, AND BILIARY FISTULA WERE NOT IDENTIFIED AS A RELATIONSHIP WITH THE SUBJECT DEVICE BECAUSE THERE IS NO INDICATION IN THE LITERATURE. OMSC ASSUMES THAT MINOR COMPLICATIONS WERE NOT IDENTIFIED AS SERIOUS ADVERSE EVENTS BECAUSE THERE IS NO INDICATION IN THE LITERATURE. WHEREAS, OMSC ASSUMES THAT THE BLEEDING REQUIRED TRANSFUSION, ADMISSION IN ICU, MAJOR COMPLICATIONS/CLAVIEN III, AND MAJOR COMPLICATIONS/CLAVIEN IV WERE A SERIOUS ADVERSE EVENT THAT CAUSES OR CONTRIBUTES TO A DEATH OR SERIOUS INJURY DUE TO HEPATIC PARENCHYMAL TRANSECTION WAS PERFORMED WITH THE SUBJECT DEVICE. OMSC ASSUMES THAT THE DEATH WAS RELATED TO THE SUBJECT DEVICE DUE TO HEPATIC PARENCHYMAL TRANSECTION WAS PERFORMED WITH THE SUBJECT DEVICE. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE WAS NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. OMSC WILL SUBMIT TWO MEDICAL DEVICE REPORTS (MDR) FOR THE OPERATIVE DEATH AND THE SERIOUS ADVERSE EVENTS. THIS REPORT IS 2 OF 2. THIS REPORT IS ABOUT THE SERIOUS ADVERSE EVENT OF THE BLEEDING REQUIRED TRANSFUSION, ADMISSION IN ICU, MAJOR COMPLICATIONS/CLAVIEN III, AND MAJOR COMPLICATIONS/CLAVIEN IV THAT MIGHT BE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1510378 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R