BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23831715 · Received December 17, 2025

    Report

    Report Number
    3021325287-2025-00079
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    April 29, 2025
    Report Date
    December 17, 2025
    Manufacturer
    NOAH MEDICAL
    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 NO ISSUES WERE FOUND ASSOCIATED WITH THIS CASE. MANUFACTURING RECORDS CONFIRMED THE SCOPE PASSED FINAL QA/QC CHECKS PRIOR TO RELEASE. THE SCOPE WAS NOT RETURNED AS IT HAD BEEN DISCARDED. VIDEO REVIEW IDENTIFIED NO USE ERRORS OR SYSTEM MALFUNCTIONS. THE PROCEDURE PROCEEDED NORMALLY, WITH NO UNINTENDED SCOPE MOVEMENTS, TOOL OVER-ADVANCEMENT, OR SYSTEM PERFORMANCE ISSUES OBSERVED. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM, STATING IT WAS MOST LIKELY RELATED TO THE PATIENT'S UNDERLYING PULMONARY FIBROSIS. GIVEN THE LESION'S PLEURAL-BASED LOCATION AND THE PATIENT'S FRAGILE LUNG CONDITION, THE EVENT IS CONSISTENT WITH KNOWN INHERENT RISKS OF BRONCHOSCOPY AND TRANSBRONCHIAL BIOPSY. VIDEO REVIEW SUPPORTS THIS ASSESSMENT AND CONFIRMS THE SYSTEM FUNCTIONED AS INTENDED.

    Description of Event or Problem · 0

    A PNEUMOTHORAX WAS IDENTIFIED AFTER COMPLETION OF A GALAXY-ASSISTED BIOPSY PROCEDURE. A PIGTAIL CHEST TUBE WAS PLACED, AND THE PATIENT WAS ADMITTED FOR OBSERVATION. THE PATIENT REMAINED STABLE AND WAS DISCHARGED THE FOLLOWING DAY. THE PATIENT HAS A KNOWN HISTORY OF PULMONARY FIBROSIS, WHICH INCREASES SUSCEPTIBILITY TO PNEUMOTHORAX. NO MALFUNCTIONS WERE REPORTED. ATTEMPTS TO GATHER PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193342 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL GALB-001 2025020701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R