BEUDAMED
    FDA Adverse Event Death Summary report: N

    MONARCH ENDOSCOPY PLATFORM

    MDR report key: 21337731 · Received February 7, 2025

    Report

    Report Number
    3014447948-2025-00002
    Event Type
    Death
    Date Received
    February 7, 2025
    Date of Event
    January 13, 2025
    Report Date
    February 7, 2025
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON000005010
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CODED DURING PROCEDURE, THE PHYSICIAN HAD CONDUCTED 4-BIOPSIES AND ON THE 5TH BIOPSY AN ABNORMAL AMOUNT OF BLOOD WAS COMING THROUGH THE ET TUBE. THE SCOPE AND THE PATIENT INTRODUCER WERE REMOVED AND THEY WERE ABLE TO STABILIZE THE PATIENT IN THE ROOM. THE PATIENT WAS MOVED TO ICU WHERE THEY LATER CODED AND PASSED AWAY. THE PHYSICIAN STATED THAT THE MONARCH DID NOT CAUSE OR CONTRIBUTE TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97330 MONARCH ENDOSCOPY PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. B634MON000005010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death