BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 21036976 · Received December 30, 2024

    Report

    Report Number
    9614641-2024-20152
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    February 10, 2021
    Report Date
    December 30, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383557
    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

    SINCE THE LITERATURE DESCRIBED "THUNDERBEAT", WE SELECTED "TB-0535FCS" AS A REPRESENTATIVE PRODUCT. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "OPERATIVE TIME, AGE, AND SERUM ALBUMIN PREDICT SURGICAL MORBIDITY AFTER LAPAROSCOPIC LIVER SURGERY." BACKGROUND: LAPAROSCOPIC LIVER RESECTION (LLR) HAS EMERGED AS A CONSIDERABLE ALTERNATIVE TO CONVENTIONAL LIVER SURGERY. HOWEVER, THE INCREASING COMPLEXITY OF LIVER RESECTION RAISES THE INCIDENCE OF POSTOPERATIVE COMPLICATIONS. THE AIM OF THIS STUDY WAS TO IDENTIFY RISK FACTORS FOR POSTOPERATIVE MORBIDITY IN A MONOCENTRIC COHORT OF PATIENTS UNDERGOING LLR. METHODS: ALL CONSECUTIVE PATIENTS WHO UNDERWENT LLR BETWEEN 2015 AND 2019 AT OUR INSTITUTION WERE ANALYZED FOR ASSOCIATIONS BETWEEN COMPLICATIONS WITH DEMOGRAPHICS AND CLINICAL AND OPERATIVE CHARACTERISTICS BY MULTIVARIABLE LOGISTIC REGRESSION ANALYSES. RESULTS: OUR COHORT COMPRISED 156 PATIENTS WHO UNDERWENT LLR WITH A MEAN AGE OF 60.0 ± 14.4 YEARS. GENERAL COMPLICATIONS AND MAJOR PERIOPERATIVE MORBIDITY WERE OBSERVED IN 19.9% AND 9.6% OF THE PATIENTS, RESPECTIVELY. MULTIVARIABLE ANALYSIS IDENTIFIED AGE>65 YEARS (HR = 2.56; P = .028) AND OPERATION TIME>180 MINUTES (HR = 4.44; P =.001) AS SIGNIFICANT PREDICTORS OF GENERAL COMPLICATIONS (CLAVIEN =1), WHILE ALBUMIN<4.3 G/DL (HR = 3.66; P = .033) AND ALSO OPERATIVE TIME (HR = 23.72; P = .003) WERE IDENTIFIED AS PREDICTORS OF MAJOR POSTOPERATIVE MORBIDITY (CLAVIEN =3). CONCLUSION: SURGICAL MORBIDITY IS BASED ON PATIENT (AGE AND PREOPERATIVE ALBUMIN) AND PROCEDURE-RELATED (OPERATIVE TIME) CHARACTERISTICS. CAREFUL PATIENT SELECTION IS KEY TO IMPROVE POSTOPERATIVE OUTCOMES AFTER LLR. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. INTRAOPERATIVE HEMORRHAGE - NUMBER OF PATIENTS NOT SPECIFIED. INTRAOPERATIVE BLOOD TRANSFUSION - 24 PATIENTS. BILIARY LEAKAGE - 4 PATIENTS. LIVER FAILURE - 3 PATIENTS. WOUND INFECTION - 3 PATIENTS. PNEUMONIA - 5 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945761 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS NI 04953170383557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention VASCULAR STAPLER (ECHELON, ETHICON)