BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZISHOT 2 FLEX

    MDR report key: 21662310 · Received March 21, 2025

    Report

    Report Number
    21662310
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    March 12, 2025
    Report Date
    March 18, 2025
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    KTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FROM STAFF: DR. ADJUSTED THE SHEATH TO THE NEEDLE AND THE NEEDLE CAME OUT THE SIDE OF THE SHEATH INSTEAD OF THE COMING OUT THE END AS INTENDED. THIS OCCURRED IN THE WORKING PORT OF THE FLEXIBLE SCOPE WHILE IT WAS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336042 VIZISHOT 2 FLEX BRONCHOSCOPE ACCESSORY KTI GYRUS ACMI, LLC NA-U403SX-4019 KR481913

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female