BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM)

    MDR report key: 11999555 · Received June 15, 2021

    Report

    Report Number
    3014447948-2021-00019
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 19, 2021
    Report Date
    May 19, 2021
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    PMA / PMN Number
    K173760
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. RISK OF PNEUMOTHORAX IS DOCUMENTED IN (B)(4), REV E, MONARCH BRONCH RISK MANAGEMENT REPORT AND IS DEEMED TO BE ACCEPTABLE. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE LABELING. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH REGULAR COMPLAINT TREND REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A MONARCH-ASSISTED BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED BLEEDING. NO BLOOD TRANSFUSION AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PNEUMOTHORAX WAS DISCOVERED DURING ENDOBRONCHIAL ULTRASOUND. THE LOCATION OF THE PNEUMOTHORAX WAS RIGHT UPPER LOBE. A CHEST TUBE WAS PLACED, AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. THE CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897009 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 MONARCH BRONCHOSCOPE SYSTEM