BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 18323026 · Received December 13, 2023

    Report

    Report Number
    3014447948-2023-00032
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    December 4, 2023
    Report Date
    January 29, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PDU ESTOP FAULT REPORTED BY THE CUSTOMER WAS CONFIRMED. A DEFINITIVE ROOT CAUSE WAS NOT ESTABLISHED FOR THE REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE AN E-STOP ERROR OCCURRED. THE PHYSICIAN WAS UNABLE TO CLEAR THE E-STOP ERROR AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1824416 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other