BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LITHOVUE

    MDR report key: 24965239 · Received April 23, 2026

    Report

    Report Number
    24965239
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 17, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGB
    UDI-DI
    08714729874805
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT A CYSTOSCOPY WITH URETERAL STENT EXCHANGE, URETEROSCOPY WITH HOLMIUM LITHOTRIPSY, RIGHT URETERAL STONE REMOVAL, RIGHT RENAL STONE REMOVAL, CYSTOLITHOLAPAXY WITH LASER. DURING THE PROCEDURE SURGEON REQUESTED TO UTILIZE A LITHOVUE DEVICE. AFTER PLUGGING IN THE DISPOSABLE IT FUNCTIONED APPROPRIATELY FOR APPROXIMATELY 30 SECONDS, BEFORE FAILING TO PRODUCE AN IMAGE. DEVICE WAS RESET AND USE ATTEMPTED AGAIN WITHOUT SUCCESS. A SECOND DISPOSABLE LITHOVUE WAS OBTAINED AND UTILIZED BY SURGEON WITHOUT ISSUE. THE MALFUNCTIONING DEVICE WAS REMOVED FROM FIELD AT END OF CASE AND PLACED IN A RED BAG ALONG WITH ITS ORIGINAL PACKAGING. REF: M0067913500, LOT: 40424407, EXP:01/15/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342443 LITHOVUE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB BOSTON SCIENTIFIC CORPORATION M0067913500 40424407 08714729874805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other