BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 16504374 · Received March 8, 2023

    Report

    Report Number
    3014447948-2023-00010
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 9, 2023
    Report Date
    April 11, 2023
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211B1
    PMA / PMN Number
    K203614
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE ANALYSIS OF THE MONARCH BRONCHOSCOPE, PRODUCT CODE: MBR-000211-B, SHOWED NO EXTERNAL DAMAGE, NO LATCHING ISSUES, AND DIMENSIONAL VERIFICATION FOR STRUCTURAL ANOMALIES YIELDED NO OBSERVED VARIANCE. A CLOSER INSPECTION OF THE SCOPE HANDLE, CABLE, AND CONNECTOR OBSERVED NO EXTERNAL PHYSICAL DAMAGE HOWEVER, A VISUAL EXAMINATION OBSERVED A KINK IN THE SHAFT APPROXIMATELY 5CM FROM SCOPE TIP. THE SCOPE WAS THEN DRIVEN THROUGH A LUNG MODEL. WHEN INITIALLY CONNECTED TO THE SYSTEM, THE SCOPE AND SHEATH WENT INTO PAIRED MODE, BUT THE SHEATH WAS NOT VISIBLE IN THE CAMERA VIEW. IMAGES OF THIS CAN BE SEEN BELOW UNDER WORKING LENGTH, WITH THE SCOPE TIP SEEN WITHIN THE LUNG MODEL. WHEN THE SCOPE WAS DRIVEN, THE SCOPE AND SHEATH DROVE INTO AN EXPECTED PAIRED MODE WHERE THE SCOPE WAS +5MM OUTSIDE OF THE SHEATH. THE SCOPE WAS DRIVEN IN PAIRED MODE AND SCOPE ONLY MODE. THE USER INTERFACE (UI) INDICATED THAT THE SCOPE/SHEATH IN PAIRED MODE WHEN PAIRED AND UNPAIRED MODE WHEN SWAPPING TO SCOPE ONLY DRIVING. THE SCOPE OPERATED AS EXPECTED. A REVIEW OF INVESTIGATIONS WITH SIMILAR REPORTED ISSUE (SCOPE AND SHEATH PAIRING ISSUE) WAS PERFORMED, HOWEVER NO SIGNIFICANT TRENDS WERE NOTED. FAILURE ANALYSIS WAS ALSO PERFORMED ON THE MONARCH SYSTEM, SOFTWARE VERSION 2.2.2., DUE TO THE REPORT OF THE CAMERA IMAGE WAS COMING IN AND OUT (RAINBOW SCREEN). AN ERROR POPULATED BUT WAS NOT CAPTURED. THE SCOPE WAS CONNECTED THROUGHOUT THIS ISSUE. THE ROOT CAUSE OF THE ISSUE CANNOT BE TRACED TO MONARCH SOFTWARE AS THE SYSTEM FUNCTION AS EXPECTED BY GENERATING THESE FAULTS WHEN CAMERA IMAGE WAS INTERMITTENT. A REVIEW FOR SIMILAR COMPLAINT SHOWS THE REPORTED ISSUE IS A KNOWN ISSUE HOWEVER THE ROOT CAUSE IS SPECIFIC TO EACH INDIVIDUAL CASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THERE ARE NO REPORTS OF NONCONFORMANCE THAT RELATE TO THE REPORTED INCIDENT. D1: MONARCH BRONCHOSCOPE. D2B: QNW. D4 MODEL: MBR-000211-B. D4 SERIAL: (B)(4). D4 UNIQUE IDENTIFIER( UDI): (B)(4). D7A: NO. D9 AVAILABLE: YES. D9: 02/16/2023. G3: 02/16/2023. G4 PMA/501(K): K203614. H2: DEVICE EVALUATION. H3: YES. H5: NO. H6: B01, B14, B24, C22, C1303, C070601, D15.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE, THERE WAS AN INTERMITTENT VIDEO FEED ISSUE WITH THE BRONCHOSCOPE PRODUCING SYSTEM ERROR CODES. USING THE FLUOROSCOPIC VIEW, THE PHYSICIAN REPORTED THE BRONCHOSCOPE APPEARED TO HAVE ¿BUCKLED BACK ON ITSELF.¿ THE PHYSICIAN TRIED DISCONNECTING THE SCOPE AND SHEATH FROM THE ROBOT ARM. INITIALLY, THE PHYSICIAN WAS UNABLE TO REMOVE THE SCOPE. THE PHYSICIAN LATER REPORTED THAT HE WAS ABLE TO REMOVE THE SCOPE FROM THE PATIENT. THE PHYSICIAN CHOSE TO ABORT THE DIAGNOSTIC PROCEDURE. THE PHYSICIAN REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790600 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-B B634MBR000211B1
    1912270 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-B B634MBR000211B1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other