BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS SHOCKPULSE

    MDR report key: 24710429 · Received March 30, 2026

    Report

    Report Number
    MW5186064
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 20, 2026
    Report Date
    March 24, 2026
    Manufacturer
    GYRUS ACMI, LLC.
    Product Code
    FEO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OLYMPUS SHOCKPULSE LITHOTRIPSY PROBE BROKE IN HALF WHILE IN USE. ALL PARTS REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404039 OLYMPUS SHOCKPULSE LITHOTRIPTOR, ULTRASONIC FEO GYRUS ACMI, LLC. KR504827

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention