BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZISHOT 2

    MDR report key: 24568011 · Received March 11, 2026

    Report

    Report Number
    24568011
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 5, 2026
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    KTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AFTER ONE USE THE NEEDLE WAS FOUND TO NOT BE WORKING CORRECTLY, AFTER INVESTIGATION BY PULMONOLOGIST, DECIDED NOT TO RE ENTER THE NEEDLE IN THE PT A NEW NEEDLE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454073 VIZISHOT 2 BRONCHOSCOPE ACCESSORY KTI GYRUS ACMI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other