BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCEND SINGLE-USE FLEXIBLE URETEROSCOPE

    MDR report key: 25111328 · Received May 7, 2026

    Report

    Report Number
    25111328
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    December 11, 2025
    Report Date
    April 17, 2026
    Manufacturer
    COOK MEDICAL LLC
    Product Code
    FGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    LASER FIBER BROKE DURING USE. CREATED HOLE/DEFECT IN DISPOSABLE FLEXIBLE URETEROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115698 ASCEND SINGLE-USE FLEXIBLE URETEROSCOPE URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FGB COOK MEDICAL LLC ASUS-86-300S HA25F091

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other