BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH

    MDR report key: 23434992 · Received October 31, 2025

    Report

    Report Number
    23434992
    Event Type
    Malfunction
    Date Received
    October 31, 2025
    Date of Event
    November 13, 2024
    Report Date
    September 9, 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

    NEW ROBOT ARMS DID NOT WORK UPON FIRST (NON-PATIENT) USE. REP WAS PRESENT AND EXCHANGED FOR NEW ARM AND THEN THE SYSTEM WORKED. MANUFACTURER RESPONSE FOR MONARCH, JOHNSON AND JOHNSON (PER SITE REPORTER). MANUFACTURER PRESENT AND EXCHANGED ROBOT ARM WHEN ISSUE WAS RECOGNIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1562009 MONARCH SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK AURIS HEALTH, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown