BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHOCKPULSE

    MDR report key: 22352631 · Received June 30, 2025

    Report

    Report Number
    22352631
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 9, 2025
    Report Date
    June 20, 2025
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    FEO
    UDI-DI
    00821925044241
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING PROCEDURE WHILE THE LITHOTRIPTER WAS ACTIVE THE PROBE BROKE IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969952 SHOCKPULSE LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI, LLC SPL-PDBX376 KR449942 00821925044241

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male