BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 15370728 · Received September 7, 2022

    Report

    Report Number
    3014447948-2022-00029
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 1, 2022
    Report Date
    September 14, 2022
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211A1
    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 INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A VISUAL EXAMINATION OF THE SCOPE HANDLE, SHAFT, AND TIP OBSERVED NO EXTERNAL DAMAGE. TO VERIFY THE SCOPE LATCHED ONTO THE INSTRUMENT DEVICE MANIPULATOR (IDM), THE SCOPE WAS THEN CONNECTED AND DISCONNECTED TO 2 DIFFERENT IDM TOP PLATES 10X EACH. THE SCOPE WAS THEN CONNECTED AND DISCONNECTED TO 2 DIFFERENT BENCHTOP IDM FIXTURES 10X EACH. THE SCOPE WAS THEN CONNECTED AND DISCONNECTED ONTO AN IN-HOUSE SYSTEM ON BOTH IDMS 10X EACH. NO LATCHING ISSUE WAS OBSERVED. DIMENSIONAL VERIFICATION FOR ANY STRUCTURAL ANOMALIES YIELDED NO VARIANCE OBSERVED. THE SUBJECT SCOPE WAS CONNECTED TO A BENCH TEST FIXTURE TO VERIFY ELECTRICAL FUNCTIONALITY OF THE CAMERA, LIGHT EMITTING DIODE (LED), AND ELECTROMAGNETIC SENSORS (EM). THE RESULTS SHOWED THE BRONCHOSCOPE TO BE OPERATING AS EXPECTED. THE SCOPE WAS THEN CONNECTED TO AN IN-HOUSE SYSTEM AND TO CONFIRM THE FUNCTIONALITY OF THE SCOPE. THE RESULTS SHOWED THE BRONCHOSCOPE TO BE OPERATING 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: 105-000299-01, REV F, MONARCH BRONCHOSCOPE RISK MANAGEMENT REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE FIRST, AND ONLY CASE OF THE DAY (1:45PM), THE RIGHT LOWER LOBE (RLL) LESION 1.5CM EXPECTED INFECTION, PHYSICIAN DID 4 BRUSHES AND PATIENT SUSTAINED A SMALL PNEUMOTHORAX. A CHEST TUBE WAS PLACED TAKING A WEEK TO RESOLVE. AURIS FORCEPS, A MICRO BRUSH (BRAND WAS NOT RECORDED), AND AN OLYMPUS PERIVIEW FLEX TBNA NEEDLE WERE ALL USED IN THIS CASE. PATIENT WAS ADMITTED AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2022 AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT IS CURRENTLY DOING WELL. THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX TO THE MONARCH SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232337 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-A B634MBR000211A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H