BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 18596309 · Received January 26, 2024

    Report

    Report Number
    MW5150830
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 17, 2024
    Report Date
    January 24, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING NAVIGATIONAL BRONCHOSCOPY, UPON REACHING THE TARGET AREA FOR SAMPLING THE LIGHT AT THE TIP OF THE SCOPE WENT DARK AND NO LONGER TURNED ON. THE SCOPE WAS REMOVED FROM THE PATIENT AND A NEW SCOPE HAD TO BE OBTAINED. MONARCH BRONCHOSCOPY PLATFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796944 MONARCH BRONCHOSCOPE REPROCESSED BRONCHOSCOPE QNW AURIS HEALTH, INC. MBR-000211-B

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male