BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23831467 · Received December 17, 2025

    Report

    Report Number
    3021325287-2025-00078
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    April 21, 2025
    Report Date
    December 17, 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. THE SCOPE WAS RETURNED FOR INVESTIGATION, AND BOTH INITIAL INSPECTION AND MANUFACTURING RECORD REVIEW CONFIRMED IT PASSED ALL FUNCTIONAL TESTS AND FINAL QA/QC RELEASE CRITERIA. THE REPORTED CAMERA FRAME-RATE ISSUE WAS EVALUATED AND FOUND TO BE A BRIEF, ONE-SECOND DROP FROM ~30 FPS TO 14 FPS, WITH IMMEDIATE RECOVERY AND NO FURTHER OCCURRENCES. THE CAMERA OPERATED RELIABLY OVERALL, AND THE TRANSIENT FRAME-RATE DIP WAS NOT TEMPORALLY ASSOCIATED WITH THE ADVERSE EVENT, MAKING IT UNLIKELY TO HAVE CONTRIBUTED TO THE PNEUMOTHORAX. VIDEO REVIEW IDENTIFIED NO USE ERRORS OR SYSTEM MALFUNCTIONS. NO UNINTENDED SCOPE OR TOOL MOVEMENTS WERE SEEN, AND THE SYSTEM FUNCTIONED AS INTENDED THROUGHOUT.. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM, STATING IT RESULTED FROM THE PLEURAL-BASED NATURE OF THE NODULE. VIDEO REVIEW SUPPORTS THIS CONCLUSION, AS THE LESION'S ANATOMY POSED AN INHERENTLY ELEVATED RISK INDEPENDENT OF DEVICE PERFORMANCE.

    Description of Event or Problem · 0

    A PNEUMOTHORAX WAS IDENTIFIED FOLLOWING A GALAXY-ASSISTED BIOPSY PROCEDURE OF A PLEURAL-BASED NODULE. A CHEST TUBE WAS INSERTED, AND NO FURTHER COMPLICATIONS OR INTERVENTIONS WERE REPORTED. THIS PATIENT IS ENROLLED IN A CLINICAL TRIAL AND IS A NONSMOKER AND HAD A LESION LOCATED AT THE PERIPHERY OF THE LUNG. A MALFUNCTION OF A CAMERA FRAME-RATE ERROR WAS REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248060 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL CORP GALB-001 6025012112

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention