BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 23423764 · Received October 30, 2025

    Report

    Report Number
    23423764
    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

    DISPOSABLE SCOPE ARRIVED FROM MANUFACTURER [MFG] WITH A "CRIMP" IN OUTER SHEATH AND SCOPE COULD NOT BE PASSED. A DIFFERENT SCOPE WAS USED AND THE DEFECTIVE SCOPE WAS RETURNED TO THE MFG. MANUFACTURER RESPONSE FOR MONARCH BRONCHOSCOPY, AURIS HEALTH (PER SITE REPORTER). UNKNOWN WHEN REPORTED TO MANUFACTURER AND RESPONSE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297093 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ AURIS HEALTH, INC. MBR-000211-A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown