BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 19706569 · Received July 9, 2024

    Report

    Report Number
    3014447948-2024-00015
    Event Type
    Injury
    Date Received
    July 9, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 7, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON000005010
    PMA / PMN Number
    K231473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS CONFIRMED THAT THE SYSTEM BEHAVED AS EXPECTED AND THE CAMERA WORKED AS DESIGNED. THE SYSTEM WAS FOUND TO MEET SPECIFICATION WITH NO ISSUE FOUND. CONFIRMED BY THE PHYSICIAN THAT THE PATIENT EVENT ASSOCIATED WITH THIS COMPLAINT WAS NOT RELATED TO THE MONARCH PLATFORM.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY AURIS HEALTH INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, AURIS HEALTH INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING THE MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A BLEED. THE PHYSICIAN REPORTED THE BLEEDING WAS NOT DUE TO MONARCH BUT RATHER JUST A RISK OF BIOPSYING THIS SPECIFIC PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544834 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 Hospitalization