BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 19122005 · Received April 16, 2024

    Report

    Report Number
    3014447948-2024-00008
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    March 25, 2024
    Report Date
    May 24, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO EM LAYING IN BETWEEN BRANCH LIKELY DUE TO CT-BODY DIVERGENCE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THERE ARE NO REPORTS OF NONCONFORMANCE THAT RELATE TO THE REPORTED INCIDENT. A REVIEW FOR SIMILAR COMPLAINT SHOWS THE REPORTED ISSUE IS A KNOWN ISSUE HOWEVER THE ROOT CAUSE IS SPECIFIC TO EACH INDIVIDUAL CASE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY AURIS HEALTH, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, AURIS HEALTH, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE DRIVING IN THE RIGHT UPPER LOB (RUL), AND 25MM OUT FROM THE TARGET, USER DECIDED TO DO A SPIN TO CONFIRM HE WAS IN LINE WITH THE LESION AND GET READY TO PLACE A DYED COIL. THE SPIN WAS DONE AND THE SCOPE WAS OBSERVED TO BE THROUGH THE LUNG AND INTO THE PLEURAE WHILE THE SYSTEM WAS SHOWING THEY WERE 25MM OUT, RESULTING IN A PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063338 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H