BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24402605 · Received February 20, 2026

    Report

    Report Number
    9614641-2026-00216
    Event Type
    Malfunction
    Date Received
    February 20, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 11, 2026
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    GEI
    UDI-DI
    04953170383557
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS SUBMITTED TO DOCUMENT THE FINDINGS AND CONCLUSIONS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION INTO THE REPORTED EVENT. ADDITIONAL INFORMATION: D4, D9. THE AFFECTED DEVICE WAS NOT RETURNED TO OLYMPUS AMERICA INC. FOR PHYSICAL INSPECTION. AS A RESULT, THE REPORTED MALFUNCTION, SPECIFICALLY, A BROKEN PROBE TIP, COULD NOT BE CONFIRMED THROUGH DIRECT DEVICE EVALUATION. BASED ON THE FINDINGS OF THE COMPLETED INVESTIGATION, AND IN THE ABSENCE OF THE RETURNED DEVICE FOR PHYSICAL EXAMINATION, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE ESTABLISHED. NO CONCLUSIVE DETERMINATION REGARDING THE FAILURE MODE OR CONTRIBUTING FACTORS COULD BE MADE. 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

    IT WAS REPORTED THAT DURING SET UP FOR THE PROCEDURE, THE PROBE TIP ON THE THUNDERBEAT DEVICE WAS BROKEN OFF. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463228 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI AOMORI OLYMPUS CO., LTD. TB-0535FCS 55K 04953170383557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown