BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 23822519 · Received December 16, 2025

    Report

    Report Number
    3011050570-2025-01472
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    August 27, 2024
    Report Date
    May 27, 2026
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K111202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2025-00306. E1: DEPARTMENT OF SURGERY, (B)(6). SINCE THE LITERATURE DESCRIBED "THUNDERBEAT", OLYMPUS SELECTED "TB-0535FC" AS A REPRESENTATIVE PRODUCT. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COMPARISON OF POSTOPERATIVE BLEED RATES AND LOCATION OF BLEED BETWEEN VESSEL SEALING DEVICES AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY." BACKGROUND: LAPAROSCOPIC SLEEVE GASTRECTOMY (SG) IS A COMMONLY PERFORMED BARIATRIC PROCEDURE. AT OUR INSTITUTION, TWO VESSEL SEALING DEVICES, THUNDERBEAT (OLYMPUS) AND MARYLAND LIGASURE (COVIDIEN) ARE UTILIZED FOR INTRAOPERATIVE DISSECTION. METHODS: A RETROSPECTIVE REVIEW OF ALL PATIENTS WHO UNDERWENT PRIMARY SG FROM JULY 2013 THROUGH AUGUST 2022 WAS PERFORMED TO EVALUATE POSTOPERATIVE BLEEDING (POB) RATES BETWEEN THE TWO DEVICES. THE PRIMARY OUTCOME MEASURED WAS POB AS DEFINED BY THE METABOLIC AND BARIATRIC SURGERY ACCREDITATION AND QUALITY IMPROVEMENT PROGRAM (MBSAQIP), WITH SECONDARY OUTCOMES INCLUDING REOPERATION, SOURCE OF BLEED, AND OVERALL SAFETY. RESULTS: A TOTAL OF 8157 UNDERWENT SG. AVERAGE BMI AND AGE WERE 43.2 KG/M2 AND 37.1 YEARS, RESPECTIVELY. A TOTAL OF 6600 (80.9%) WERE FEMALE. THUNDERBEAT WAS UTILIZED IN 5143 (63%) CASES AND MARYLAND LIGASURE WAS USED IN 3014 (37%) CASES. THERE WAS NO SIGNIFICANT DIFFERENCE IN OVERALL BLEEDING BETWEEN THE THUNDERBEAT (18/5143, .35%) AND THE MARYLAND LIGASURE (19/3014, .63%; P = .0689). HOWEVER, THERE WAS A DIFFERENCE NOTED WHEN COMPARING REOPERATION FOR BLEEDING BETWEEN THUNDERBEAT (9/5143, .17%) AND MARYLAND LIGASURE (13/3014, .43%; P = .0291). FURTHERMORE, THE LOCATION OF BLEEDING IN THE REOPERATIONS WAS MORE COMMON FROM THE CUT EDGE OF THE MESENTERY COMPARED TO THE STAPLE LINE WITH THE MARYLAND LIGASURE VERSUS THE THUNDERBEAT (P =.038). TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: POSTOPERATIVE BLEEDING (POB) (18 POB EVENTS) REOPERATIONS (A TOTAL OF 9 POB) BLOOD TRANSFUSION WITH THE AVERAGE OF 2.39 UNITS, WITH THE OPERATIVE GROUP RECEIVING 3.22 UNITS AND THE NONOPERATIVE GROUP RECEIVING 1.56 UNITS. CONCLUSIONS: THE THUNDERBEAT DEVICE IS COMPARATIVELY MORE HEMOSTATIC THAN THE MARYLAND LIGASURE FOR SG. THE LOCATION OF POSTOPERATIVE BLEED MAY BE RELATED TO VESSEL SEALING DEVICES USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464072 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI GYRUS ACMI, INC. TB-0535FC NI 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention