BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 18597523 · Received January 29, 2024

    Report

    Report Number
    3014447948-2023-00035
    Event Type
    Injury
    Date Received
    January 29, 2024
    Date of Event
    January 4, 2024
    Report Date
    January 29, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    UDI-DI
    B634MBR000211B1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT IS BASED ON INFORMATION WHICH HAS BEEN INVESTIGATED OR VERIFIED. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED PNEUMOTHORAX IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE LABELING. A VISUAL EXAMINATION OF THE SCOPE HANDLE, SHAFT, AND TIP OBSERVED NO EXTERNAL DAMAGE EXCEPT OBSERVED KINK IN THE SCOPE JACKET 10MM FROM THE SCOPE HANDLE. 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 BRONCHOSCOPE DID NOT MEET SPECIFICATIONS DUE TO OBSERVED KINK ON SCOPE JACKET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED A PNEUMOTHORAX IN THE RIGHT LUNG. A CHEST TUBE WAS PLACED AND PATIENT WAS HOSPITALIZED. THE FOLLOWING DAY THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS RELEASED. THE PHYSICIAN STATED THAT THE SCOPE APPEARED TO BE KINKED AND THE PHYSICIAN ELECTED TO ABORT THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648573 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC. MBR-000211-B B634MBR000211B1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R