BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 15230044 · Received August 15, 2022

    Report

    Report Number
    3014447948-2022-00022
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    July 7, 2022
    Report Date
    August 15, 2022
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211A1
    PMA / PMN Number
    K193534
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. A THOROUGH VISUAL INSPECTION, BOTH EXTERNALLY AND INTERNALLY WITH A BAROSCOPE, FOUND NO MISSING PARTS OR PIECES THAT WOULD ACCOUNT FOR A WHITE FB THAT COULD HAVE BEEN FROM THE SCOPE. IT WAS REQUESTED THAT THE CUSTOMER SEND BACK THE ¿WHITE FB¿ PIECE FOR FAILURE ANALYSIS INVESTIGATION. HOWEVER, THE CUSTOMER HAD DISCARDED THE WHITE FB. THE FLUIDICS TUBING AND AURIS FORCEPS WERE ALSO DISCARDED BEFORE BEING RETURNED FOR INVESTIGATION. 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. A REVIEW OF INVESTIGATIONS HAS NOTED THAT THIS IS AN ISOLATED ISSUE AND HAS NO ESTABLISHED A ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    H10: THE REPORTED ISSUE OCCURRED ON A DEVICE USED FOR DIAGNOSIS AND NOT TREATMENT. BECAUSE THE REPORTED ISSUE IS ASSOCIATED WITH SCOPE PERFORMANCE, AN EXAMINATION OF THE SUBJECT SCOPE WAS PERFORMED. THE CUSTOMER REPORTED THAT WHEN THE CUSTOMER INTRODUCED RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE IT PUSHED A PIECE OF WHITE PLASTIC OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. CUSTOMER WAS ABLE TO REMOVE A PIECE OF PLASTIC WITH FORCEPS AND WAS ABLE TO COMPLETE THE CASE. A REVIEW OF COMPLAINT HISTORY REPORTED ISSUE (FRAGMENT FELL IN PATIENT) HAS NOTED THAT THIS IS AN ISOLATED ISSUE AND THE FIRST EVENT OF ITS KIND BUT HAS NOT ESTABLISHED A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN NAVIGATED TO THE LESION, AND WHEN THE RADIAL ENDOBRONCHIAL ULTRASOUND (REBUS) PROBE WAS INTRODUCED, IT PUSHED A SMALL WHITE FOREIGN BODY (FB) OUT OF THE MONARCH SCOPE INTO THE PATIENT'S LUNGS. THE PHYSICIAN WAS ABLE TO REMOVE THE FB USING FORCEPS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237418 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