BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 18946316 · Received March 20, 2024

    Report

    Report Number
    3014447948-2024-00007
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    January 3, 2024
    Report Date
    April 19, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K231473
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    LOG AND VIDEO INVESTIGATION WAS PERFORMED. THE REPORTED PNEUMOTHORAX CANNOT BE TIED TO ANY MALFUNCTION OR DEFECT OF THE SYSTEM THAT OCCURRED DURING THE PROCEDURE. THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE TRACED TO MONARCH SYSTEM AS THE VIDEO AND LOG INVESTIGATION CANNOT CONFIRM THE OCCURRENCE OF PNEUMOTHORAX DURING PROCEDURE. 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 REPORTED THAT THE NAVIGATION WAS NOT MATCHING UP WITH THE CIOS SPIN AND WAS ~30MM OFF FROM THE TARGET BUT THE CASE WAS COMPLETED SUCCESSFULLY. A PNEUMOTHORAX WAS DISCOVERED POST-OP AND THE PATIENT WAS NOT ADMITTED BUT A CHEST TUBE WAS PLACED. CHEST TUBE WAS REMOVED SAME DAY AND THE PATIENT WENT HOME SAME DAY. THERE WERE NO FAULTS OR ISSUES REPORTED WITH THE MONARCH SYSTEM AND THE PHYSICIAN IS NOT ATTRIBUTING THE EVENT TO THE MONARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700691 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention