BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 14951435 · Received July 7, 2022

    Report

    Report Number
    3014447948-2022-00014
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    June 8, 2022
    Report Date
    July 7, 2022
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211A1
    PMA / PMN Number
    K203614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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. NO LATCHING ISSUE WAS OBSERVED. DIMENSIONAL VERIFICATION FOR ANY STRUCTURAL ANOMALIES YIELDED NO VARIANCE OBSERVED. 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. IT WAS REPORTED THAT THE SCOPE WAS DRIVEN TO THE LESION AND WAS BACKING OUT A TEAR WAS NOTICE IN THE AIRWAY WHICH WAS BELIEVED TO HAVE BEEN CAUSE BY THE SHEATH. A CLOSER INSPECTION OF BOTH THE SHEATH AND THE SCOPE SHOWED NO VISIBLE DAMAGE WITH SHARP PROTRUSIONS THAT WOULD HAVE CONTRIBUTED TO THE TEAR IN THE AIRWAY. A REVIEW OF THE SYSTEM LOGS SHOWED THE OCCURRENCE OF FAULT ID: (B)(4) ¿SCOPE BUCKLING¿ AND MULTIPLE OCCURRENCES OF FAULT ID: (B)(4) ¿ROBOT COLLISION¿. IT IS LIKELY THAT THE CUSTOMER ENCOUNTERED SCOPE BUCKLING WHILE DRIVING TOWARD THE TARGET LOCATION AND PHYSICALLY EXERTED FORCE ON THE SCOPE AND SHEATH TO RESOLVE THE BUCKLING ISSUE WHICH TRIGGERED THE OCCURRENCE OF FAULT ID: (B)(4) ¿ROBOT COLLISION¿. 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 WITH SIMILAR REPORTED ISSUE (TEAR IN AIRWAY) HAS NOTED THAT THIS IS AN ISOLATE INCIDENT AND HAS NOT ESTABLISHED A POSSIBLE ROOT CAUSE. RISK DOCUMENT NUMBER: (B)(4). RISK ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A TEAR IN THE AIRWAY. THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND DISCHARGED FOLLOWING DAY. THE PHYSICIAN NAVIGATED TO THE LESION IN PAIRED MODE. AT SOME POINT THE PHYSICIAN DROPPED THE SHEATH AND ADVANCED THE SCOPE ONLY. AT THE LESION, THE PHYSICIAN ADVANCED THE SHEATH ONLY TO PROVIDE MORE STABILITY WHILE INTRODUCING BIOPSY TOOLS. WHEN THE PHYSICIAN HAD COMPLETED AND RETRACTED BOTH THE SCOPE AND SHEATH THE PHYSICIAN NOTICED A TEAR IN THE AIRWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2865959 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-A B634MBR000211A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R