BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEM BRONCHOSCOPE

    MDR report key: 25075959 · Received May 4, 2026

    Report

    Report Number
    3021325287-2026-00015
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 4, 2026
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR HAS BEEN SUBMITTED BECAUSE ARM RETRACTION, NOT EXPECTED BY THE USER, OCCURRED DURING A GALAXY-ASSISTED PROCEDURE. THE INVESTIGATION REVIEWED MANUFACTURING RECORDS AND SYSTEM INFORMATION FROM THE CASE. ANALYSIS DETERMINED THE OBSERVED RETRACTION WAS CAUSED BY A FALSE POSITIVE SCOPE DISCONNECTION REGISTERED BY THE SYSTEM, MOST LIKELY DUE TO AN UNSTABLE POGO CONNECTION AT THE INTERFACE DEVICE MODULE (IDM) AND BRONCHOSCOPE INTERFACE. THIS RETRACTION OCCURRED DURING THE USE OF THE SECOND BRONCHOSCOPE AND NOT THE THIRD AS INITIALLY REPORTED IN B5. NO PATIENT HARM WAS REPORTED. THIS MDR IS BEING SUBMITTED PROACTIVELY BECAUSE RECURRENCE OF THIS MALFUNCTION COULD POTENTIALLY RESULT IN SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE GALAXY SYSTEM, THE USER REPORTED THAT THE SYSTEM DID NOT CONSISTENTLY RECOGNIZE WHEN A BRONCHOSCOPE WAS ATTACHED. WHEN THE SCOPE WAS RECOGNIZED, NO CAMERA FEED WAS PRESENT OR THE IMAGE QUALITY WAS REPORTED AS POOR AND INTERMITTENT. THREE BRONCHOSCOPES WERE USED DURING THE PROCEDURE. ALL THREE SCOPES EXHIBITED INTERMITTENT CAMERA SIGNAL, WITH ONE SCOPE NOT OBTAINING CAMERA SIGNAL. DURING USE OF THE THIRD SCOPE, AN ARM RETRACTION EVENT OCCURRED. THE RETRACTION OCCURRED AFTER SYSTEM INITIALIZATION AND SHORTLY AFTER THE SYSTEM DISPLAYED "AWAITING CAMERA SIGNAL." THE ARM RETRACTION OCCURRED WHILE THE PHYSICIAN WAS PERFORMING EBUS AND WHILE TROUBLESHOOTING ACTIVITIES WERE ONGOING. FOLLOWING A SYSTEM REBOOT, THE ISSUE PERSISTED, INCLUDING BRIEF CAMERA SIGNAL FOLLOWED BY LOSS OF SIGNAL AND ANOTHER ARM RETRACTION EVENT. THE PROCEDURE WAS NOT COMPLETED USING THE GALAXY SYSTEM. NO PATIENT INJURY WAS REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561824 GALAXY SYSTEM BRONCHOSCOPE GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 6025112405

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown EBUS.