BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 24066689 · Received January 14, 2026

    Report

    Report Number
    24066689
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    December 12, 2025
    Report Date
    December 24, 2025
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHAT: FAULTY EQUIPMENT. MONARCH SCOPE BENT UPON REMOVING FROM PACKAGING. PULLED 2ND SCOPE FOR USE WHICH HAD MUCH MORE OF THE NORMAL CURVATURE THAN THE REF MBR-000211-B. SN [REDACTED]. EXPIRATION 2026-07-15. WHY: WHY: DEFECTIVE DISPOSABLE MONARCH SCOPE. HOW: MONARCH HAS BEEN HAVING PRODUCTION ISSUES WITH THE DISPOSABLE MONARCH SCOPES. THIS IS THE FOURTH IDENTIFIED INCIDENT. SAFETY NET HAS BEEN COMPLETED AND MED-SUN PAPERWORK WILL BE COMPLETED FOR THIS INCIDENT. OUTCOME: [REDACTED], THE PATIENT, SUCCESSFULLY HAD A MONARCH PROCEDURE PERFORMED WITH NO ISSUES. NOTE: [REDACTED], ENDOSCOPY MANAGER, HAS REQUESTED A FULL MONARCH SCOPE PRODUCT EXCHANGE WITH [REDACTED], MONARCH REPRESENTATIVE. [REDACTED], ENDOSCOPY MANAGER, HAS SCHEDULED A MEETING ON [REDACTED] WITH [REDACTED], MONARCH REPRESENTATIVE AND [REDACTED] LEADERSHIP INCLUDING [REDACTED], [REDACTED], [REDACTED], AND [REDACTED] TO ADDRESS THE PRODUCTION ISSUES AND ANY OTHER CONCERNS RELATED TO MONARCH EQUIPMENT. [REDACTED], ENDOSCOPY MANAGER, WILL SCHEDULE A SECOND MEETING TO ADDRESS THE CT SLICE ISSUES THAT HAVE RESULTED IN MULTIPLE MONARCH PROCEDURE CANCELLATIONS. THIS WAS SUPPOSED TO OCCUR ON [REDACTED], BUT THE MONARCH TEAM REPRESENTATIVES THAT ADDRESS CT IMAGING AND UPLOADS ARE NOT AVAILABLE ON [REDACTED] PER [REDACTED], MONARCH REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128213 MONARCH BRONCHOSCOPE REPROCESSED BRONCHOSCOPE QNW AURIS HEALTH, INC. MBR-000211-B

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male