BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH PLATFORM

    MDR report key: 20214179 · Received September 13, 2024

    Report

    Report Number
    3014447948-2024-00019
    Event Type
    Malfunction
    Date Received
    September 13, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 13, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON000005010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED FROM THE LOG REVIEW AND IN-HOUSE TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN EXPERIENCED ISSUES WITH THE ROBOTIC ARM AND DECIDED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208047 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000005-01 B634MON000005010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown