BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZISHOT 2 FLEX

    MDR report key: 22911545 · Received August 28, 2025

    Report

    Report Number
    22911545
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    June 19, 2025
    Report Date
    August 18, 2025
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    KTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING BRONCHOSCOPY EBUS [ENDOBRONCHIAL ULTRASOUND] THE STYLET ON THE SINGLE USE ASPIRATION NEEDLE, 19G, BECAME STUCK AND WOULD NOT ADVANCE OR WITHDRAW. SPECIMENS COULD NOT BE OBTAINED, AND NEW DEVICE (21G) OBTAINED TO CONTINUE PROCEDURE AND RETRIEVE SPECIMENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419347 VIZISHOT 2 FLEX BRONCHOSCOPE ACCESSORY KTI GYRUS ACMI, LLC NA-U403SX-4019 KR470017

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Unknown