BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONARCH BRONCHOSCOPE

    MDR report key: 19868821 · Received July 30, 2024

    Report

    Report Number
    3014447948-2024-00016
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 30, 2024
    Manufacturer
    AURIS HEALTH, INC.
    Product Code
    QNW
    PMA / PMN Number
    K203614
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REMOVAL OF H6 (F1909). THE SUBJECT SCOPE WAS TESTED AND MET SPEC. A CLOSER INSPECTION OF THE SCOPE HANDLE, SHAFT, CABLE, AND CONNECTOR OBSERVED NO EXTERNAL PHYSICAL DAMAGE THAT COULD CONTRIBUTE TO THE REPORTED ISSUE. THE FAILURE ANALYSIS CONFIRMED THAT THE SYSTEM REPORTED ON ARM ID 30 HOLDING FOR ROBOT JOINT ERROR WAS CONFIRMED THROUGH LOGS.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED DURING A MONARCH BRONCHOSCOPY PROCEDURE IT APPEARED THAT THE SCOPE RETRACTED BY A FEW CENTIMETERS, WHICH TRIGGERED THE JOINT FOLLOWING ERROR. THE PHYSICIAN WAS UNABLE TO CLEAR ERROR AND ELECTED TO ABORT THE CASE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT BECAUSE OF THE SYSTEM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733616 MONARCH BRONCHOSCOPE BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES QNW AURIS HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other