BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23633899 · Received November 24, 2025

    Report

    Report Number
    3021325287-2025-00058
    Event Type
    Injury
    Date Received
    November 24, 2025
    Date of Event
    May 8, 2024
    Report Date
    November 24, 2025
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Product Problem
    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 MANUFACTURING RECORDS CONFIRMED IT PASSED FINAL QA/QC TESTING. INSPECTION FOUND A LARGE TISSUE FRAGMENT LODGED IN THE WORKING CHANNEL, INCREASING TOOL RESISTANCE WHEN THE SCOPE WAS HIGHLY ARTICULATED. THIS MECHANICAL RESISTANCE WAS DETERMINED TO BE UNRELATED TO THE BLEEDING, WHICH OCCURRED LATER DURING BIOPSY ACTIVITY. THE REPORTED ROBOT COLLISION ERROR WAS REVIEWED AND CORRELATED WITH EXCESSIVE PROCEDURAL FORCE APPLIED BY THE USER; SYSTEM LOGS CONFIRMED APPROPRIATE ACTIVATION OF THE E-STOP, INDICATING THE GALAXY SYSTEM FUNCTIONED AS DESIGNED. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE GALAXY SYSTEM, STATING THE INJURY OCCURRED AT THE BIOPSY SITE. BASED ON AVAILABLE INFORMATION, THE BLEEDING WAS PROCEDURE-RELATED AND CONSISTENT WITH THE KNOWN INHERENT RISKS OF BRONCHOSCOPY, PARTICULARLY IN PATIENTS WITH FRAGILE AIRWAYS AND SIGNIFICANT COMORBIDITIES. THIS COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSIONS: BLEEDING WAS REPORTED DURING A GALAXY-ASSISTED BIOPSY PROCEDURE. THE BLEEDING WAS NOTED TOWARD THE END OF SAMPLING, FOLLOWING DIFFICULTY ADVANCING THE BIOPSY TOOL AND A ROBOT COLLISION ERROR. THE GALAXY SCOPE WAS WITHDRAWN, AND UPON REINSERTION, BLOOD WAS OBSERVED WITHIN THE AIRWAY. A THERAPEUTIC SCOPE WAS THEN INTRODUCED TO TAMPONADE THE BLEEDING, AND ICE-COLD SALINE WAS ADMINISTERED. NO FURTHER COMPLICATIONS OR INTERVENTIONS WERE REPORTED.

    Description of Event or Problem · 0

    BLEEDING WAS OBSERVED TOWARD THE END OF BIOPSY SAMPLING WHILE ATTEMPTING THE THIRD FORCEPS BIOPSY. THE GALAXY SCOPE WAS WITHDRAWN, AND A THERAPEUTIC SCOPE WAS INTRODUCED TO TAMPONADE THE BLEEDING WHILE ICE-COLD SALINE WAS ADMINISTERED. UPON REINSERTION, BLOOD WAS STILL NOTED IN THE AIRWAY, PROMPTING THE PHYSICIAN TO END THE PROCEDURE. NO FURTHER COMPLICATIONS OR INTERVENTIONS WERE REPORTED. PRIOR TO THE THIRD BIOPSY, THE TEAM EXPERIENCED DIFFICULTY PASSING THE BIOPSY TOOL AND APPLIED INCREASED FORCE, WHICH TRIGGERED A ROBOT COLLISION ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340849 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 2024021402

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention