BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 15288653 · Received August 24, 2022

    Report

    Report Number
    9614641-2022-00198
    Event Type
    Death
    Date Received
    August 24, 2022
    Date of Event
    July 10, 2021
    Report Date
    September 14, 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
    GM
    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. 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 FROM THE AUTHOR AND THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE 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. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, SAFETY OF LAPAROSCOPIC HEPATECTOMY IN PATIENTS WITH SEVERE COMORBIDITIES-A PROPENSITY SCORE MATCHED ANALYSIS." LITERATURE SUMMARY: [ABSTRACT] BACKGROUND: LAPAROSCOPIC HEPATECTOMY (LH) IS NOWADAYS CONSIDERED AS THE STANDARD OF CARE FOR VARIOUS LIVER MALIGNANCIES. HOWEVER, STUDIES FOCUSING ON PERIOPERATIVE OUTCOME AFTER LH IN PATIENTS WITH SEVERE COMORBIDITIES ARE STILL SPARSE. METHODS: 247 PATIENTS, WHO UNDERWENT LH BETWEEN JANUARY 2016 AND MARCH 2020 AT EUROPEAN SURGICAL CENTER AACHEN MAASTRICHT (ESCAM) WERE RETROSPECTIVELY ANALYZED REGARDING SURGICAL OUTCOME. ALL PATIENTS WERE CATEGORIZED ACCORDING TO THE ASA GUIDELINES AND A PROPENSITY SCORE MATCHED (PSM) ANALYSIS WAS PERFORMED TO COMPARE PATIENTS WITH SEVERE COMORBIDITIES WITH PATIENTS WITH MINOR OR NO COMORBIDITIES. RESULTS: AFTER PSM, NO STATISTICALLY SIGNIFICANT DIFFERENCES REGARDING CLINICAL CHARACTERISTICS WERE OBSERVED. WE PERFORMED MAJOR RESECTIONS IN 26.4% OF H-ASA(ASA > 2) PATIENTS AND 19.4% OF 1-ASA (ASA<2) PATIENTS, RESPECTIVELY (P = .322).OVERALL MORBIDITY (CLAVIEN-DINDO>1) WAS OBSERVED MORE FREQUENTLY IN THE H-ASA GROUP (H-ASA: 25.0% VS. 1-ASA: 8.3%; P = .007) WHILE ANALYSIS OF MAJOR MORBIDITY(CLAVIEN-DINDO>3B) SHOWED A NON-SIGNIFICANT TENDENCY FOR MORE COMPLICATIONS IN H-ASA PATIENTS (H-ASA: 8.3% VS. 1-ASA: 1.4%; P = .053). A SUBGROUP ANALYSIS IDENTIFIED MAJOR RESECTION (HR = 5.05; P = .006) AS AN INDEPENDENT RISK FACTOR FOR THE OCCURRENCE OF ANY POSTOPERATIVE COMPLICATION AND CHRONIC KIDNEY DISEASE (HR = 22.59;P = .030) AND LIVER FIBROSIS (HR = 30.16; P = .031) AS RISK FACTORS FOR THE OCCURRENCE OF MAJOR COMPLICATIONS IN H-ASA PATIENTS. CONCLUSION: LH IN PATIENTS WITH SEVERE SYSTEMIC COMORBIDITIES SHOWS A STRONG TENDENCY TOWARDS AN INCREASED RATE OF MAJOR COMPLICATIONS. CAREFUL PATIENT SELECTION WITH RESPECT TO THE PLANNED EXTENT OF RESECTION AND THE PRESENCE OF CHRONIC KIDNEY DISEASE AND LIVER FIBROSIS SHOULD BE PERFORMED TO IMPROVE PERIOPERATIVE RESULTS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: CLAVIEN-DINDO V (DEATH) - 4. ACUTE KIDNEY INJURY - 2. URINARY TRACT INFECTION - 3. HYPOKALEMIA - 2. SURGICAL SITE INFECTION - 6. BINARY LEAKAGE - 5. ACUTE LIVER FAILURE - 1. WOUND INFECTION - 3. PNEUMONIA - 6. THIS ARTICLE INCLUDES 2 REPORTS: (B)(6) (FOR INJURY), (B)(6) (FOR DEATH). THIS COMPLAINT IS (B)(6).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICES DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS. THE AUTHOR STATED THE EVENTS HAPPENED MAINLY DUE TO THE CONDITION OF THE PATIENT'S LIVER, AND THERE WAS NO MALFUNCTION OF THE OLYMPUS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828491 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 Death NON-OLYMPUS DEVICE: CAUTERY| NON-OLYMPUS DEVICE:ULTRASONIC SURGICAL ASPIRATOR| NON-OLYMPUS:VASCULAR STAPLERS OR POLYMER CLIP