BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)

    MDR report key: 25263057 · Received May 22, 2026

    Report

    Report Number
    3014447948-2026-00026
    Event Type
    Injury
    Date Received
    May 22, 2026
    Report Date
    May 22, 2026
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE HAS BEEN REVIEWED: TITLE: ROBOT-ASSISTED BRONCHOSCOPY FOR LUNG NODULE DIAGNOSIS: A PILOT FEASIBILITY STUDY AUTHORS: U. CHADDHA, S. P. KOVACS, C. MANLEY, M. SHENDE, S. MURGU, D. K. HOGARTH DOI: NOT PROVIDED. THE AIM OF THIS STUDY IS TO EVALUATE THE FEASIBILITY OF PERFORMING RAB IN CONSECUTIVE PATIENTS WITH LUNG NODULES REFERRED FOR BRONCHOSCOPIC BIOPSY. BETWEEN (B)(6) 2018, A TOTAL OF 82 PATIENTS UNDERWENT RAB PROCEDURES WITH THE MONARCH PLATFORM (AURIS SURGICAL ROBOTICS, (B)(6) CA). THIS REPORT IS BEING SUBMITTED FOR THE FOLLOWING REPORTED COMPLICATIONS ARE: N=4.8%; PNEUMOTHORAX TREATMENT: NOT MENTIONED N= 3.7%; SIGNIFICANT BLEEDING TREATMENT: NOT MENTIONED N=69.5%; BRONCHUS SIGN (INCLUDING LESIONS WITH AN AIRWAY GOING TO THE NODULE EDGE) TREATMENT: NOT MENTIONED N=1; CASE WAS ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543267 MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other