BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH PLATFORM

    MDR report key: 20446642 · Received October 14, 2024

    Report

    Report Number
    3014447948-2024-00022
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 16, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K231473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    THE ROOT CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE SEGMENTATION ALGORITHM FAILURE DUE TO ABNORMAL PATIENT ANATOMY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THERE ARE NO REPORTS OF NONCONFORMANCE THAT RELATE TO THE REPORTED INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE AFTER INITIALIZATION, THE SOFTWARE INSTRUCTS USER TO NAVIGATE IN THE OPPOSITE WAY OF THE TARGET. THE PHYSICIAN ELECTED TO ABORT THE CASE. THERE WAS NO REPORT OF AN ADVERSE EVENT DUE TO SYSTEM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716829 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown