BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23513452 · Received November 10, 2025

    Report

    Report Number
    3021325287-2025-00044
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    February 8, 2024
    Report Date
    November 7, 2025
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM AND BRONCHOSCOPE MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. FAILURE ANALYSIS CONFIRMED THE SCOPE PASSED FINAL QA/QC TESTING. VIDEO REVIEW COULD NOT BE PERFORMED DUE TO LOG UNAVAILABILITY. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM, DETERMINING IT WAS PROCEDURE-RELATED AND CAUSED BY THE LESION'S SMALL SIZE AND PROXIMITY TO THE PLEURA, FACTORS THAT MADE IT A HIGH-RISK SITE FOR BIOPSY. THE EVENT IS CONSISTENT WITH THE KNOWN INHERENT RISKS OF BRONCHOSCOPY. THIS COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PNEUMOTHORAX OCCURRED DURING A GALAXY-ASSISTED BIOPSY PROCEDURE. A CHEST TUBE WAS INSERTED, AND THE PATIENT WAS ADMITTED AND DISCHARGED THE SAME DAY. THE PHYSICIAN DID NOT ATTRIBUTE THE INJURY TO THE GALAXY SYSTEM, DETERMINING IT WAS RELATED TO THE LESION'S LOCATION AND NATURE. NO MALFUNCTIONS WERE REPORTED.

    Description of Event or Problem · 0

    A PNEUMOTHORAX OCCURRED DURING THE PROCEDURE WHILE PERFORMING A BIOPSY. A CHEST TUBE WAS INSERTED, AND THE PATIENT WAS DISCHARGED LATER THE SAME DAY IN STABLE CONDITION. NO MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525621 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 2023111601

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention