BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23897335 · Received December 26, 2025

    Report

    Report Number
    3021325287-2025-00070
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    September 17, 2024
    Report Date
    December 26, 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. MANUFACTURING RECORDS CONFIRMED THAT THE SCOPE PASSED FINAL QA/QC TESTING PRIOR TO RELEASE. VIDEO REVIEW IDENTIFIED NO USE ERRORS OR SYSTEM MALFUNCTIONS. BIOPSIES WERE PERFORMED UNDER LIVE FLUOROSCOPY, AND NEITHER THE TOOL NOR THE SCOPE EXCEEDED AF BOUNDARIES. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE GALAXY SYSTEM, NOTING THAT IT APPEARED TO ORIGINATE FROM THE FORCEPS BIOPSY. BASED ON ALL AVAILABLE INFORMATION, THE EVENT IS MOST CONSISTENT WITH THE KNOWN INHERENT RISKS OF BRONCHOSCOPY AND TRANSBRONCHIAL BIOPSY.

    Description of Event or Problem · 0

    BLEEDING WAS OBSERVED IN THE RIGHT UPPER LOBE (RUL) FOLLOWING A FORCEPS BIOPSY AND PROGRESSIVELY INCREASED AFTER ADDITIONAL FORCEPS BIOPSIES. THE GALAXY SCOPE WAS LEFT IN PLACE AND TRANEXAMIC ACID WAS ADMINISTERED LOCALLY THROUGH THE WORKING CHANNEL. THE GALAXY BRONCHOSCOPE WAS THEN REMOVED, AND A THERAPEUTIC SCOPE WAS INSERTED THROUGH THE ENDOTRACHEAL TUBE (ETT) TO VISUALIZE, CLEAN THE AIRWAY, AND ASSESS FOR CONTINUED BLEEDING. THE PATIENT WAS STABILIZED AND ADMITTED FOR 4 DAYS. NO MALFUNCTIONS WERE REPORTED. ATTEMPTS TO GATHER PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344868 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL CORP GALB-001 2024071801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H