BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)

    MDR report key: 11898931 · Received May 27, 2021

    Report

    Report Number
    3014447948-2021-00013
    Event Type
    Injury
    Date Received
    May 27, 2021
    Date of Event
    May 6, 2021
    Report Date
    May 6, 2021
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    PMA / PMN Number
    K173760
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED FROM THE TRANSBRONCHIAL BIOPSY ASSISTED BY ROBOT GUIDANCE IN THE EVALUATION OF TUMORS OF THE LUNG (TARGET) STUDY. (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. THE RISK OF PNEUMOTHORAX IS DOCUMENTED IN (B)(4), MONARCH BRONCH RISK MANAGEMENT REPORT. BASED ON THE INFORMATION AVAILABLE FOR THIS EVENT, THE ROOT CAUSE IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS DISCOVERED VIA A CHEST X-RAY AFTER THE PROCEDURE WHEN THE PATIENT WAS AWAKE AND COMPLAINED ABOUT CHEST PAIN. THE TARGET AND PNEUMOTHORAX LOCATION WERE IN THE LEFT LOWER LOBE (LLL). A CHEST TUBE WAS PLACED IN THE PATIENT AND THE PATIENT WAS HOSPITALIZED. THE CHEST TUBE WAS REMOVED, AND PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793181 MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000005

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R