BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23804015 · Received December 15, 2025

    Report

    Report Number
    3021325287-2025-00072
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    September 27, 2024
    Report Date
    December 12, 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

    THE SCOPE WAS NOT RETURNED FOR INVESTIGATION, AND MANUFACTURING RECORDS CONFIRMED IT PASSED FINAL QA/QC. VIDEO REVIEW SHOWED NO USE ERRORS OR MALFUNCTIONS. THE LESION WAS POSITIONED EXTREMELY CLOSE TO THE DIAPHRAGM, AND WHILE THE BIOPSY TOOL REMAINED WITHIN AF BOUNDARIES. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX OR MEDIASTINAL EROSION TO THE GALAXY SYSTEM, STATING THE EVENT WAS MOST LIKELY RELATED TO THE LESION'S LOCATION AND THE BIOPSY TOOL. VIDEO REVIEW SUPPORTS THIS ASSESSMENT, SHOWING APPROPRIATE TECHNIQUE AND STABLE SCOPE BEHAVIOR WITH NO DEVICE-RELATED CONTRIBUTION.

    Description of Event or Problem · 0

    THE PHYSICIAN NAVIGATED TO AN RML NODULE AND COMPLETED SAMPLING USING FORCEPS BIOPSIES UNDER GOOD VISUALIZATION. DURING THE FINAL BIOPSY, IT WAS NOTED THAT THE LESION HAD ERODED THROUGH THE MEDIASTINUM. SAMPLING WAS STOPPED, AND THE CASE WAS CONCLUDED. THE PATIENT WAS REVERSED, EXTUBATED, AND TRANSFERRED TO PACU IN STABLE CONDITION. A CHEST X-RAY IDENTIFIED A SMALL RIGHT PNEUMOTHORAX. BECAUSE THE PATIENT REMAINED STABLE AND ASYMPTOMATIC, A NON-REBREATHER MASK WAS APPLIED TO SUPPORT REABSORPTION. A REPEAT X-RAY ONE HOUR LATER SHOWED INTERVAL DECREASE IN PNEUMOTHORAX SIZE, THOUGH STILL PRESENT, AND THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. NO MALFUNCTIONS WERE REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789522 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL CORP GALB-001 2024072401

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Unknown Hospitalization