BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 15249489 · Received August 18, 2022

    Report

    Report Number
    3014447948-2022-00023
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    July 19, 2022
    Report Date
    September 9, 2022
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211A1
    PMA / PMN Number
    K203614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RISK OF PNEUMOTHORAX IS DOCUMENTED IN (B)(4), REV F, MONARCH BRONCHOSCOPE RISK MANAGEMENT REPORT AND IS DEEMED TO BE ACCEPTABLE. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE LABELING.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: 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. THE CUSTOMER REPORTED THAT THE SCOPE APPEARED TO HAVE ¿AUTO RELAX WITHOUT BEING INITIATED, NO ERRORS OCCURRED ON THE SCREEN.¿ IT WAS ALSO REPORTED THAT THE CASE WAS COMPLETED BUT THE PATIENT HAD SUFFERED A PNEUMOTHORAX AFTER THE SCOPE WAS REMOVED. A REVIEW OF THE CASE VIDEO SHOWED THAT FAULT ID: 1001-50-0-0 ¿CONTROLLER HW ERROR¿ HAD OCCURRED WHEN THE CUSTOMER WAS RETRACTING FROM THE PATIENT. A FAULT ID: 1001-50-0-0 ¿CONTROLLER HW ERROR¿ IS DEFINED AS ¿WHEN SYSTEM IS IN DRIVE MODE AND PENDANT IS UPSIDE DOWN OR EXPERIENCES AN IMPACT OR EXPERIENCES FREE-FALL.¿ IT IS LIKELY THAT IF THE CUSTOMER BRIEFLY LOST CONTROL OF THE CONTROLLER, THE SCOPE WOULD HAVE LOST TENSION AND APPEARED TO HAVE ¿AUTO RELAXED¿. A REVIEW OF THE CALIBRATION DATA OBTAINED FROM PRODUCT FINAL ACCEPTANCE TESTING REVEALED ALL ACCEPTANCE CRITERIA WERE MET AND NO ANOMALIES FOUND. BASED ON THE RESULTS FROM THE EXAMINATION, THE PRODUCT MET SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX DURING THE REMOVAL BRONCHOSCOPE. THE PATIENT WAS HOSPITALIZED, AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED, AND THE PATIENT WAS DISCHARGED TWO DAYS LATER. THE TARGET LOCATION WAS LEFT UPPER LOBE (LUL). IT WAS REPORTED THAT A HUGE SNAPPING AND STRAIGHTENING OF THE BRONCHOSCOPE OCCURRED DURING THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530296 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