BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEM

    MDR report key: 24903831 · Received April 16, 2026

    Report

    Report Number
    3021325287-2026-00012
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 16, 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 RETRACTION, NOT EXPECTED BY THE USER, OCCURRED DURING A GALAXY-ASSISTED BIOPSY PROCEDURE. THE INVESTIGATION REVIEWED MANUFACTURING RECORDS, THE RETURNED BRONCHOSCOPE, AND SYSTEM LOG FILES FROM THE CASE. ANALYSIS DETERMINED THE OBSERVED RETRACTION WAS CAUSED BY A REGISTERED DISCONNECTION SIGNAL AT THE SCOPE MOUNTING INTERFACE. NO PATIENT HARM WAS REPORTED. THIS MDR WAS SUBMITTED PROACTIVELY BECAUSE RECURRENCE OF THIS MALFUNCTION COULD POTENTIALLY RESULT IN SERIOUS INJURY.

    Description of Event or Problem · 0

    DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, A FALSE POSITIVE SCOPE DISCONNECTION CAUSED THE ARM TO RETRACT UNEXPECTEDLY WHILE THE SCOPE WAS PHYSICALLY ATTACHED TO THE SYSTEM. NO PATIENT HARM WAS REPORTED DURING THE CASE. THE PROCEDURE WAS SUBSEQUENTLY CONTINUED USING A DIFFERENT SCOPE. PATIENT DEMOGRAPHICS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961860 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 6025101706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown