BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 24269295 · Received February 5, 2026

    Report

    Report Number
    9614641-2026-00153
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Report Date
    May 20, 2026
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383571
    PMA / PMN Number
    K211838
    Removal / Correction Number
    3003995201-12/09/2024-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NOTE: THE CUSTOMER RETURNED TWO DEVICES FOR EVALUATION, NEITHER OF WHICH MATCHED THE ITEM AND LOT # INITIALLY REPORTED (AS CAPTURED IN INITIAL MDR OF RELATED REPORT NUMBER). CUSTOMER COULD NOT DISCERN WHICH PRODUCT WAS INVOLVED WITH THE REPORTED EVENT. THEREFORE, THE RESULTS OF BOTH DEVICE INVESTIGATION WILL BE PROVIDED UPON COMPLETION. D4, H4: 1. TB-0520FCS - LOT NO: 54K 08, EXPIRY DATE: 31-MAR-2028, MFG DATE: 08-APR-2025. 2. TB-0520FCS - LOT NO: 57K 31. THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE THUNDERBEAT'S PROBE BROKE IMMEDIATELY AFTER IT WAS ACTIVATED DURING UNSPECIFIED USE. ADDITIONAL DETAILS WERE REQUESTED FROM THE CUSTOMER BUT THE INFORMATION WAS UNKNOWN. THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547190 THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0520FCS 57K 31 04953170383571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown