BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE-SE LITHOTRIPSY SYSTEM

    MDR report key: 21903531 · Received April 24, 2025

    Report

    Report Number
    3011050570-2025-00403
    Event Type
    Malfunction
    Date Received
    April 24, 2025
    Date of Event
    April 21, 2025
    Report Date
    November 11, 2025
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FEO
    PMA / PMN Number
    K142428
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    THE MDR SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE UPDATED FIELDS AND FINAL INVESTIGATION RESULTS. UPDATED FIELDS: H2, H6, H11. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE CUSTOMER'S ALLEGATION COULD NOT CONFIRMED. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, THE DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD FAILED TO ACTIVATE. THE ISSUE WAS FOUND DURING SEDATION OF CYSTO LITHO PXY THERAPEUTIC PROCEDURE. IT WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227910 SHOCKPULSE-SE LITHOTRIPSY SYSTEM LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI, INC. SPL-S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown