BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 18921615 · Received March 18, 2024

    Report

    Report Number
    3014447948-2024-00005
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 18, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211A1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT SCOPE WAS CONNECTED TO AN IN-HOUSE SYSTEM TO VERIFY ELECTRICAL FUNCTIONALITY OF THE CAMERA, LIGHT EMITTING DIODE (LED), AND ELECTROMAGNETIC SENSORS (EM). THE SCOPE TIP WAS MANUALLY ARTICULATED WHILE MONITORING THE RESISTANCE OF EACH SENSOR, AND THE CAMERA IMAGE TO CONFIRM THAT THERE WAS NO INTERMITTENT OPEN ON EITHER SENSOR OR CAMERA IMAGE DEGRADATION. THE RESULTS OBSERVED BOTH SENSORS TO BE WITHIN SPECIFICATION, AND THE CAMERA TO BE FUNCTIONAL WITH NO SIGNS OF IMAGE DEGRADATION. ADDITIONALLY, THE LED WAS NOT FUNCTIONING. THE SCOPE WAS CONNECTED TO THE IN-HOUSE SYSTEM FOR THIRTY MINUTES AND NO LED WAS OBSERVED. A CLOSER INSPECTION OF THE SCOPE HANDLE, SHAFT, CABLE, AND CONNECTOR OBSERVED NO EXTERNAL PHYSICAL DAMAGE THAT COULD CONTRIBUTE TO THE REPORTED ISSUE. NOTE: MANUFACTURER REPORT NUMBERS 3014447948-2024-00004 ARE FOR THE SAME PATIENT EVENT.

    Description of Event or Problem · 0

    THE CLINICAL SPECIALIST REPORTED THAT DURING THE PROCEDURE, THE LIVE CAMERA VIEW ON THE SCOPE SUDDENLY BECAME STATIC AND FUZZY, LEADING TO A LOSS OF VIEW. THE USER SWITCHED SCOPES AND SUCCESSFULLY NAVIGATED TO THE LESION. HOWEVER, WHILE BIOPSYING, AN FAULT OCCURRED, INDICATING DISCONNECTION OF THE SCOPE AND DISABLING OF ROBOTIC FUNCTIONS. DESPITE ATTEMPTS, THE USER COULDN'T TURN THE CAMERA BACK ON OR CLEAR THE ERROR. THE CLINICAL SPECIALIST MENTIONED THAT THE ISSUE RECURRED WITH THE SECOND SCOPE DURING BIOPSYING. CONSEQUENTLY, THE PHYSICIAN DECIDED TO END THE PROCEDURE WITHOUT FURTHER BIOPSIES. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SCOPE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186219 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-A B634MBR000211A1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other