BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 15370487 · Received September 7, 2022

    Report

    Report Number
    3014447948-2022-00028
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 5, 2022
    Report Date
    September 7, 2022
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211B0
    PMA / PMN Number
    K203614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE LABELING. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. DURING THE INVESTIGATION OF THIS RETURNED DEVICE, A VISUAL INSPECTION FOUND NO EXTERNAL DAMAGE OF THE DEVICE OR ITS RETURN PACKAGING. THE ABILITY OF THE DEVICE TO LATCH WAS TESTED ON MULTIPLE TEST FIXTURES AS WELL AS AN IN-HOUSE MONARCH SYSTEM ON BOTH INSTRUMENT DEVICE MANIPULATORS (IDM). STRUCTURAL DIMENSIONAL VERIFICATION CONFIRMED ALL MEASUREMENTS TO BE WITHIN SPECIFICATION. BENCH TESTING WAS PERFORMED ON THE RETURNED DEVICE TO VERIFY ELECTRICAL FUNCTIONALITY OF THE CAMERA, LIGHT EMITTING DIODE (LED), AND ELECTROMAGNETIC SENSORS (EM). THE RESULT OF THE TESTS FOUND THE DEVICE TO BE WITHIN SPECIFICATIONS. THE DEVICE WAS THEN LOADED TO AN IN-HOUSE SYSTEM AND DRIVEN THROUGH A LUNG MODEL. THE DEVICE FUNCTIONED AS EXPECTED. BASED ON THE RESULTS FROM THE EXAMINATION, THE MONARCH BRONCHOSCOPE USED ON THE MONARCH PLATFORM HAS MET SPECIFICATIONS AND THERE WERE NO ISSUES FOUND WITH THE MONARCH BRONCHOSCOPE. RISK DOCUMENT NUMBER: 105-000198-01, REV. E, MONARCH BRONCH RISK MANAGEMENT REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING MONARCH BRONCHOSCOPY PROCEDURE PATIENT EXPERIENCED PNEUMOTHORAX. LESION IN THE LINGULA 1.7 X 9 CM. LESION WAS PERIPHERAL. CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED, AND RELEASED ON (B)(6) 2022. THE CASE WAS COMPLETED AND THE PHYSICIAN DID NOT ATTRIBUTE THE EVENT TO THE MONARCH SPECIFICALLY. OTHER INSTRUMENTS USED IN THIS CASE WERE THE ARCPOINT NEEDLE, OLYMPUS CYTOLOGY BRUSH, OLYMPUS MICRO BRUSH, AND OLYMPUS ENDOJAW DISPOSABLE BIOPSY FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459198 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-B B634MBR000211B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R