BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH DISPOSABLE SCOPE

    MDR report key: 23434935 · Received October 31, 2025

    Report

    Report Number
    23434935
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    August 14, 2025
    Report Date
    September 9, 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

    THE SCOPE WAS IN PARK AND SUPPOSED TO STAY IN PLACE. THE SCOPE DID NOT STAY IN PLACE, CAUSING THE NEEDLE TO MOVE AROUND. MD NEEDED TO STICK THE PT MULTIPLE TIMES WITH DIFFERENT SAMPLING TOOLS. MANUFACTURER RESPONSE FOR MONARCH DISPOSABLE SCOPE, MONARCH (PER SITE REPORTER). UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076649 MONARCH DISPOSABLE SCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) EOQ AURIS HEALTH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Other