BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23524533 · Received November 11, 2025

    Report

    Report Number
    3021325287-2025-00045
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    February 12, 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. THE MAIN CARINA MATCH ISSUE AND INACCURATE DISTANCE TO LESION WERE INVESTIGATED AND BOTH WERE RESOLVED THROUGH NORMAL WORKFLOW (TOMO UPDATE AND REPEAT TILT), WITH NO EVIDENCE THEY CONTRIBUTED TO THE EVENT. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM, DETERMINING IT WAS RELATED TO THE BIOPSY OR REBUS. THE EVENT IS CONSISTENT WITH THE KNOWN INHERENT RISKS OF BRONCHOSCOPY. THIS COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PNEUMOTHORAX WAS REPORTED FOLLOWING A GALAXY-ASSISTED BIOPSY PROCEDURE. A CHEST TUBE WAS INSERTED, AND THE PATIENT WAS ADMITTED OVERNIGHT. THE PHYSICIAN DID NOT ATTRIBUTE THE INJURY TO THE GALAXY SYSTEM, STATING IT WAS PROCEDURE-RELATED AND LIKELY ASSOCIATED WITH EITHER THE BIOPSY OR REBUS. TWO MALFUNCTIONS: MAIN CARINA MATCH ISSUE AND INACCURATE DISTANCE TO LESION, WERE REPORTED.

    Description of Event or Problem · 0

    THE PNEUMOTHORAX WAS IDENTIFIED POST-PROCEDURE AND IMAGING WAS NOT PROVIDED, MAKING THE LOCATION OF THE INJURY RELATIVE TO THE TARGET LESION INCONCLUSIVE. A CHEST TUBE WAS INSERTED, AND THE PATIENT WAS ADMITTED OVERNIGHT. MALFUNCTIONS REPORTED INCLUDED MAIN CARINA MATCH ISSUE AND INACCURATE DISTANCE TO LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034346 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 2023110703

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R