BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 20349416 · Received October 1, 2024

    Report

    Report Number
    3014447948-2024-00021
    Event Type
    Malfunction
    Date Received
    October 1, 2024
    Date of Event
    September 4, 2024
    Report Date
    October 14, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    PMA / PMN Number
    K231473
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS FROM BENCHTOP TESTING OBSERVED THE LED WAS NOT WORKING. THEREFORE, DESTRUCTIVE TESTING WAS PERFORMED. THE LED WAS REMOVED FROM THE SCOPE SHAFT, A VISUAL CHECK WAS PERFORMED ON LED WIRE AND DISCOVERED BLACK LED WIRE WAS BROKEN IN THE SHAFT NEAR ARTICULATION SECTION 20MM FROM THE TIP.

    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 THAT DURING THE MONARCH BRONCHOSCOPY PROCEDURE WHILE NAVIGATING TO THE SECOND TARGET AFTER REREGISTRATION, TARGET ON THE SAME SIDE VIDEO WOULD TURN WHITE, COME BACK AND THEN TURN BLACK. PHYSICIAN HAD THE BIOPSY FROM THE FIRST TARGET AND DID NOT WANT TO REPLACE THE SCOPE. SHE ABORTED 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
    2007070 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown