BEUDAMED
    FDA Adverse Event Death Summary report: N

    MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)

    MDR report key: 23587366 · Received November 18, 2025

    Report

    Report Number
    3014447948-2025-00031
    Event Type
    Death
    Date Received
    November 18, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 18, 2025
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROBOTICALLY ASSISTED BRONCHOSCOPY PROCEDURE, AS THE PHYSICIAN WAS TAKING ANTERIOR/POSTERIOR SCOUT SHOTS USING A 3D C-ARM, THE PATIENT BEGAN TO EXHIBIT IRREGULAR HEART RHYTHMS. THE PHYSICIAN DECIDED TO ABORT THE PROCEDURE. THE PATIENT WENT INTO ATRIAL FIBRILLATION AND CODED. CHEST COMPRESSIONS WERE STARTED IMMEDIATELY. THE CODE CONTINUED FOR 30 - 35 MINUTES, AND THE PATIENT PASSED AWAY. NO BIOPSIES OR NEEDLE ASPIRATIONS WERE PERFORMED DURING THE PROCEDURE. NO ISSUES WERE REPORTED INVOLVING THE DEVICES USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644497 MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death GE OEC 3D C-ARM.| MONARCH BRONCHOSCOPE.| REBUS INSTRUMENT.