BEUDAMED
    FDA Adverse Event Death Summary report: N

    MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)

    MDR report key: 24274522 · Received February 5, 2026

    Report

    Report Number
    3014447948-2026-00004
    Event Type
    Death
    Date Received
    February 5, 2026
    Date of Event
    September 13, 2023
    Report Date
    February 5, 2026
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING BRONCHOSCOPY, THE PATIENT BECAME HYPOTENSIVE. THE CRITICAL CARE PULMONOLOGY TEAM WAS CALLED TO THE BEDSIDE. A CHEST TUBE WAS INSERTED AND AN IMMEDIATE GUSH OF AIR WAS OBSERVED. SHORTLY THEREAFTER THE PATIENT ARRESTED AND CPR WAS INITIATED. A LARGER-BORE CHEST TUBE WAS PLACED, RESULTING AGAIN IN A GUSH OF AIR. THE PATIENT WAS PRONOUNCED DEAD BY THE CRITICAL CARE TEAM. NECROTIC MATERIAL WAS EXPELLED DURING THE EVENT. A RAB (ROBOT-ASSISTED BRONCHOSCOPY) WITH 7-NEEDLE ASPIRATION WAS PERFORMED. THE DEATH WAS PRESUMED TO BE DUE TO A TENSION PNEUMOTHORAX. NO ISSUES WERE REPORTED WITH THE DEVICES USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335841 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| R PERIVIEW NEEDLE