BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PLATFORM

    MDR report key: 15979056 · Received December 14, 2022

    Report

    Report Number
    3014447948-2022-00041
    Event Type
    Injury
    Date Received
    December 14, 2022
    Date of Event
    November 15, 2022
    Report Date
    December 14, 2022
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MON0000060
    PMA / PMN Number
    K211493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR SYSTEM 120147 AND THERE WERE NO NON-CONFORMANCES RELATED TO THE PNEUMOTHORAX REPORTED IN THIS CASE. 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. RISK DOCUMENT NUMBER: (B)(4) REV F, MONARCH BRONCH RISK MANAGEMENT REPORT RISK ID: PNEUMOTHORAX.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY PROCEDURE THE PATIENT EXPERIENCED PNEUMOTHORAX ON THE LEFT SIDE A CHEST TUBE WAS PLACED, THE PATIENT WAS HOSPITALIZED AND DISCHARGED THE NEXT DAY. THE MEDTRONIC ARCPOINT WAS ALSO USED. PHYSICIAN ATTRIBUTES THIS PNEUMOTHORAX TO USE OF THE MONARCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141830 MONARCH PLATFORM BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MON-000006 B634MON0000060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R