BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 23423736 · Received October 30, 2025

    Report

    Report Number
    23423736
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    August 21, 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

    DURING THE PROCEDURE, THE SCOPE LOST NAVIGATION ABILITY. COULD NOT GET PAST THE "ROLL CORRECTION" PHASE OF THE PROCEDURE. SCOPES SWITCHED DURING PROCEDURE WHICH DELAYED CASE BY 7 MINUTES. MANUFACTURER RESPONSE FOR MONARCH DISPOSABLE BRONCHOSCOPY, AURIS HEALTH (PER SITE REPORTER). UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2408459 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ AURIS HEALTH, INC. MBR-000211-A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male