BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23136012 · Received September 24, 2025

    Report

    Report Number
    3021325287-2025-00030
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    July 24, 2024
    Report Date
    September 24, 2025
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE PHYSICIAN PERFORMED TWO NEEDLE BIOPSIES AND SIX FORCEPS BIOPSIES. AFTER THE SIXTH FORCEPS BIOPSY, THE SCOPE WAS WITHDRAWN FROM THE AIRWAY. APPROXIMATELY FIFTEEN SECONDS LATER, THE ENDOTRACHEAL TUBE (ETT) FILLED WITH BLOOD. TO CONTROL THE BLEEDING, THE PHYSICIAN INTRODUCED A THERAPEUTIC SCOPE, WEDGED IT IN THE AIRWAY, AND INSTILLED MEDICATION. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE USE OF THE GALAXY DEVICE, BUT RATHER TO THE FINAL TRANSBRONCHIAL FORCEPS BIOPSY. SCOPE BUCKLING WAS REPORTED EARLIER IN THE PROCEDURE; HOWEVER, THIS EVENT DID NOT CAUSE OR CONTRIBUTE TO THE BLEEDING. THE FIRST BUCKLING NOTIFICATION OCCURRED WHEN THE SCOPE TIP WAS 52.5 MM AWAY FROM THE LESION, WHILE THE BLEEDING ORIGINATED FROM THE LESION SITE IN THE RIGHT UPPER LOBE. FURTHERMORE, MULTIPLE BIOPSIES WERE SUCCESSFULLY PERFORMED AFTER THE BUCKLING ERROR WAS RECEIVED AND THE TARGET WAS ACCESSED, CONFIRMING NO CORRELATION BETWEEN THE SCOPE BUCKLING AND THE BLEEDING EVENT. DEVICE EVALUATION WAS PERFORMED ON THE RETURNED SCOPE AND CONFIRMED THAT NO MALFUNCTION OCCURRED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE PHYSICIAN PERFORMED TWO NEEDLE PASSES AND FORCEPS PASSES. FOLLOWING THE SIXTH FORCEPS PASS, THE SCOPE WAS WITHDRAWN. APPROXIMATELY 15 SECONDS AFTER SCOPE WITHDRAWAL, THE ENDOTRACHEAL TUBE (ETT) FILLED WITH BLOOD. THE PHYSICIAN THEN USED A THERAPEUTIC SCOPE TO CONTROL THE BLEEDING BY WEDGING IT IN THE AIRWAY AND INSTILLING MEDICATION. DURING THE PROCEDURE, THE PHYSICIAN ALSO RECEIVED SCOPE BUCKLING ERROR NOTIFICATIONS. THE PHYSICIAN DOES NOT ATTRIBUTE THE EVENT TO THE USAGE OF GALAXY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493087 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention