BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 23050530 · Received September 15, 2025

    Report

    Report Number
    23050530
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 12, 2025
    Report Date
    August 29, 2025
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    FGO
    UDI-DI
    00821925027701
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    OLYMPUS ULTRA-CATCH NT- NO TIP NITINOL BASKET DOESN'T WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952182 OLYMPUS DISLODGER, STONE, FLEXIBLE FGO GYRUS ACMI, LLC NT4W22115 KR498877 00821925027701

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male