BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 20340481 · Received September 30, 2024

    Report

    Report Number
    3014447948-2024-00020
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 3, 2024
    Report Date
    October 10, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    PMA / PMN Number
    K231473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT SCOPE WAS CONNECTED TO AN IN-HOUSE BENCHTOP TEST FIXTURE. NO LED WAS OBSERVED. A CLOSER INSPECTION OF THE SCOPE HANDLE, SHAFT, CABLE, AND CONNECTOR OBSERVED A SMALL KINK 57MM FROM THE SCOPE TIP. THE BORESCOPE INSPECTION CONFIRMED A CORRELATING KINK IN THE INNER DIAMETER AS WELL.

    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 THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE WHILE NAVIGATING TO VERY DIFFICULT TO REACH TARGET (SHARP TURN), VIDEO FROM THE SCOPE WAS LOST. IT CAME BACK IN A MOMENT BUT THE PHYSICIAN DECIDED TO SWITCH TO EBUS. PHYSICIAN WAS NOT ABLE TO REACH THE TARGET WITH EBUS EITHER SO THE CASE WAS ABORTED. THERE WAS NO REPORT OF AN ADVERSE EVENT DUE TO SYSTEM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39731 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown