BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 23423641 · Received October 30, 2025

    Report

    Report Number
    23423641
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 10, 2025
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LOST NAVIGATION IN THE BEGINNING OF CASE. HAD TO SWITCH OUT SCOPES TO CONTINUE WITH CASE. MANUFACTURER RESPONSE FOR MONARCH BRONCHOSCOPY, MONARCH (PER SITE REPORTER). UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342664 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ AURIS HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male