BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18096634 · Received November 8, 2023

    Report

    Report Number
    9614641-2023-01674
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 8, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THIS EVENT. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    AN OLYMPUS SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER, DURING A HYSTERECTOMY, THE THUNDERBEAT EXPERIENCED A BREAKAGE OF THE ACTIVE BLADE WITHIN 10 TO 15 MINUTES OF USE. THE NORMAL DURATION OF THE PROCEDURE WAS 90 MINUTES DUE TO THE INCIDENT, WITH AN ADDITIONAL 10 MINUTES. THE THERAPEUTIC HYSTERECTOMY WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT HARM OR INJURY ASSOCIATED WITH THIS EVENT. USAGE OF SUBJECT DEVICE THE USG-400 (ULTRASONIC GENERATOR) SOFTWARE VERSION WAS 2.00. THE SETTING OF ITM (INTELLIGENT TISSUE MONITORING) ¿ON¿ WHEN THE THUNDERBEAT WAS USED. IN THE HOSPITAL, THE SETTING OF ITM IS USUALLY ¿ON¿ WHEN THE THUNDERBEAT WAS USED. THE USER UNDERSTOOD CHARACTERISTICS OF ITM FUNCTIONALITY. THE USER DID NOT CHANGE THE ITM SETTING DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781922 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS KR335865 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown