BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZISHOT 2 FLEX

    MDR report key: 20832085 · Received December 3, 2024

    Report

    Report Number
    20832085
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 19, 2024
    Manufacturer
    GYRUS ACMI, LLC
    Product Code
    KTI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    EBUS (ENDOBRONCHIAL ULTRASOUND) NEEDLE USED DURING BRONCHOSCOPY WITH ENDOBRONCHIAL ULTRASOUND FINE NEEDLE ASPIRATION AND TRANSBRONCHIAL BIOPSY. STAFF REPORTED THE GUIDEWIRE WAS HARD TO PUSH THROUGH THE CHANNEL. NEEDLE WOULD COME OUT OF THE SHEATH WHEN IT WAS NOT IN THE SCOPE, BUT ONCE IN THE SCOPE, IT WOULD NOT COME OUT. NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544138 VIZISHOT 2 FLEX BRONCHOSCOPE ACCESSORY KTI GYRUS ACMI, LLC NA-U403SX-4019 KR442690

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male