BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 15807348 · Received November 16, 2022

    Report

    Report Number
    3014447948-2022-00039
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    November 11, 2022
    Report Date
    January 3, 2023
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211A1
    PMA / PMN Number
    K203614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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. 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 SCOPE TIP WAS MANUALLY ARTICULATED WHILE MONITORING THE RESISTANCE OF EACH SENSOR TO CONFIRM THAT THERE WAS NO INTERMITTENT OPEN ON EITHER SENSOR. THE RESULTS SHOWED OBSERVED BOTH SENSORS TO BE WITHIN SPECIFICATION. THE SCOPE WAS LEFT CONNECTED TO THE IN-HOUSE SYSTEM FOR THIRTY MINUTES AND THE IMAGE WAS OBSERVED TO BE STABLE AND CLEAR. A CLOSER INSPECTION OF THE SCOPE HANDLE, SHAFT, CABLE, AND CONNECTOR OBSERVED NO PHYSICAL DAMAGE THAT COULD CONTRIBUTE TO THE REPORTED ISSUE. THE RESULTS SHOWED THE BRONCHOSCOPE TO BE OPERATING AS EXPECTED. THE SCOPE WAS THEN CONNECTED TO AN IN-HOUSE SYSTEM TO CONFIRM THE FUNCTIONALITY OF THE SCOPE. THE SCOPE WAS THEN DRIVEN THROUGH A LUNG MODEL AND WAS SUCCESSFULLY ABLE TO BE INITIALIZED WITHOUT RECEIVING A FAULT ID: 1205-50-0-0 NAV INITIALIZATION ERROR. SEE IMAGES BELOW. ALTHOUGH THERE WAS NO VIDEO AVAILABLE FOR REVIEW DURING THE CASE, A REVIEW OF THE PLAN ID FAULTS CONFIRMED THE OCCURRENCE OF 1205 FAULT. A REVIEW OF THE CALIBRATION DATA OBTAINED FROM PRODUCTION 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 SIMILAR INVESTIGATIONS WITH SIMILAR REPORTED ISSUE (1205 NAV INITIALIZATION) HAS NOTED THAT THIS IS A KNOWN ISSUE AND HAVE NOT ESTABLISHED A POSSIBLE ROOT CAUSE. RISK DOCUMENT NUMBER: 105-000369-00 REV K DFMEA SOFTWARE BRONCH 2.0. NO FURTHER ACTION IS NEEDED BASED ON THE RISK ACCEPTANCE. THIS ISSUE WILL BE TRACKED AND TRENDED IN THE MONTHLY COMPLAINT TREND REVIEW MEETINGS.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PHYSICIAN EXPERIENCED A 1205-50-0-0 FAULT WHEN PRESSING THE ¿SET¿ DURING ROLL CORRECTION. THE PHYSICIAN REPOSITIONED THE FIELD GENERATOR, POWER CYCLED THE SYSTEM, AND SWITCHED TO A SECOND SCOPE, HOWEVER, THE ISSUE PERSISTED. THE PHYSICIAN CHOSE TO ABORT THE PROCEDURE AND RESCHEDULE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE SYSTEM FAULT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1416031 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. B634MBR000211A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown