BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH CONTROLLER

    MDR report key: 23434884 · Received October 31, 2025

    Report

    Report Number
    23434884
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 10, 2025
    Manufacturer
    AURIS HEALTH, INC
    Product Code
    JAK
    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 CASE, THE MONARCH CONTROLLER TWICE GAVE THE ERROR "FAULT ID: 500-30-5-307. ROBOT CONTROLLER ERROR. A SYSTEM ERROR HAS OCCURRED. ALL ROBOTIC FUNCTIONS HAVE BEEN DISABLED. TO RESOLVE, UNLOAD AND RELOAD THE BRONCHOSCOPE AND CLICK OK TO ACKNOWLEDGE THE FAULT. THEN RE-INITIALIZE NAVIGATION AT MAIN CARINA." ONCE CASE WAS COMPLETED, DURING STOWING OF ROBOTIC ARMS, THE CODE POPPED UP AND LOCKED ARMS IN THE UPRIGHT POSITION. THEY HAD TO SHUT DOWN THE MONARCH AND INSTALL A NEW CONTROLLER. MANUFACTURER RESPONSE FOR MONARCH CONTROLLER, MONARCH (PER SITE REPORTER). UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907279 MONARCH CONTROLLER SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK AURIS HEALTH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male