BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 24686535 · Received March 25, 2026

    Report

    Report Number
    24686535
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 17, 2026
    Report Date
    March 13, 2026
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    MONARCH BRONCHOSCOPY FAILED TO INITIALIZE AND ENGAGE IN ROBOT. ERROR CODES CAME UP. MONARCH REP WAS PRESENT DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183595 MONARCH BRONCHOSCOPE REPROCESSED BRONCHOSCOPE QNW AURIS HEALTH, INC. MBR-000211-B 2508260705

    Patients

    Seq Age Sex Outcome Treatment
    1