BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 15336094 · Received September 1, 2022

    Report

    Report Number
    3014447948-2022-00026
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    August 2, 2022
    Report Date
    September 1, 2022
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    EOQ
    UDI-DI
    B634MBR0000141
    PMA / PMN Number
    K193534
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO AURIS HEALTH, INC. AS THE PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B1, G3, G6, H2, H6, H10, H11 THE CUSTOMER REPORTED THAT THERE WERE NO FAULTS OR MALFUNCTIONS FROM THE ROBOT. FAILURE ANALYSIS WAS UNABLE TO CONFIRM THE OCCURRENCE OF ANY FAULTS OR ERRORS RELATED TO THE REPORTED ISSUE. SOURCE: S3: 2022-08-02/SYSTEM120113/{3A9CE66C-2B4C-4A1B-96FF-9183F0B12FFC}. A REVIEW OF THE CASE VIDEO DID CONFIRM THE REPORTED EVENT WHERE THE CUSTOMER MADE A PASS WITH THE MONARCH FORCEPS AND THE PATIENT BEGAN TO BLEED. THE PRODUCT DEVELOPMENT MANAGER (PDM) REPORTED THAT THE MONARCH FORCEPS WERE DISCARDED AND WOULD NOT BE AVAILABLE FOR FAILURE ANALYSIS INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR SYSTEM120113 AND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED INCIDENT IN THIS CASE. ADDING B1: PRODUCT PROBLEM AS CASE WAS ABORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A MONARCH BRONCHOSCOPY A PATIENT WAS BLEEDING IN THE RIGHT MIDDLE LOBE FOLLOWING THE USE OF A MEDTRONIC ARCPOINT NEEDLE AND THE MONARCH FORCEPS. THE BLEEDING OBSTRUCTED THE PHYSICIAN¿S VIEW AND WAS NOTED IN THE ENDOTRACHEAL TUBE. THE MONARCH PORTION OF THE CASE WAS ABORTED, AND THE PHYSICIAN PERFORMED AN EMERGENT CONVERSION TO REMOVE THE ROBOT AND ATTEMPTED TO CONTROL THE BLEEDING. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AND TRANSPORTED TO THE OPERATING ROOM (OR). WHEN IN THE OR, THE PHYSICIAN, WHILE UNDER BRONCHOSCOPIC GUIDANCE, WAS ABLE TO CONTROL THE BLEEDING VIA BRONCHOSCOPE VISUALIZATION AND EPINEPHRINE. PATIENT WAS DISCHARGED TWO DAYS LATER AND IS DOING WELL. NO FAULTS OR MALFUNCTIONS WERE REPORTED FROM SYSTEM. THE MONARCH FORCEPS WERE DISCARDED DURING THE EVENT AND WILL NOT BE RETURNED FOR FAILURE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830843 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES EOQ AURIS HEALTH, INC. MBR-000014 B634MBR0000141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R