BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23897337 · Received December 26, 2025

    Report

    Report Number
    3021325287-2025-00087
    Event Type
    Injury
    Date Received
    December 26, 2025
    Date of Event
    July 30, 2025
    Report Date
    December 26, 2025
    Manufacturer
    NOAH MEDICAL
    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. HARDWARE EVALUATION IDENTIFIED SHINGLING WITHIN THE BENDING SECTION AND A KINKED SHAFT LOCATED 5.35 INCHES FROM THE DISTAL TIP. FUNCTIONAL TESTING CONFIRMED THAT THE SCOPE ARTICULATED AND RESPONDED APPROPRIATELY TO INSERTION AND RETRACTION COMMANDS IN ALL DIRECTIONS. ADDITIONAL BENCH TESTING CONFIRMED CONTROLLER RESPONSIVENESS, WITH SOME PERFORMANCE DEGRADATION NOTED, INCLUDING LIMITED ARTICULATION IN CERTAIN DIRECTIONS AND INTERMITTENT CAMERA/LED BEHAVIOR, CONSISTENT WITH THE PRESENCE OF THE SHAFT KINK. NO EXPOSED SHARP EDGES OR DISTAL TIP DEFECTS WERE IDENTIFIED. INVESTIGATION OF THE REPORTED "REVERSE CONTROLS" AND SCOPE PROLAPSE DETERMINED THAT THE PERCEIVED REVERSE MOTION WAS A MECHANICAL EFFECT OF SEVERE SCOPE PROLAPSE. CHANGES IN SHAFT GEOMETRY DURING COMMANDED RETRACTION ALLOWED THE SCOPE TO SLIP FORWARD WITHIN THE AIRWAY, CREATING THE APPEARANCE OF REVERSED CONTROL INPUT. SYSTEM LOGS CONFIRMED THAT COMMANDED MOTIONS WERE APPROPRIATE AND CONSISTENT WITH USER INPUT. PROCEDURE REVIEW CONFIRMED THAT THE USER CONTINUED ADVANCING THE SCOPE DESPITE RECEIVING AND ACKNOWLEDGING ON-SCREEN INSTRUCTIONS TO RETRACT IN RESPONSE TO UNEXPECTED SCOPE SHAPE ALERTS. CONTINUED ADVANCEMENT WHILE THE SCOPE TIP WAS OBSTRUCTED RESULTED IN SIGNIFICANT PROLAPSE AND RETROFLEXION WITHIN THE AIRWAY. SUBSEQUENT STRAIGHTENING OF THE SCOPE WAS FOLLOWED BY THE ONSET OF BLEEDING OBSERVED IN THE CAMERA VIEW. THE SHAFT KINK IDENTIFIED ON THE RETURNED SCOPE IS MOST CONSISTENT WITH MECHANICAL STRESS INCURRED DURING THE PROLAPSE AND RETROFLEXION EVENT RATHER THAN A PRE-EXISTING DEFECT. DESPITE THE KINK, THE SCOPE MAINTAINED APPROPRIATE ARTICULATION AND RESPONSE TO CONTROLLER COMMANDS, CONFIRMING THAT CONTROL WAS NOT LOST OR REVERSED. VIDEO REVIEW CONFIRMED THAT NO GALAXY SYSTEM MALFUNCTIONS OCCURRED AND IDENTIFIED A SINGLE PRIMARY USE ERROR AS THE CAUSE OF THE BLEEDING. THE SYSTEM FUNCTIONED AS INTENDED BY DETECTING UNSAFE SCOPE SHAPE AND ISSUING ALERTS. THE BLEEDING IS MOST CONSISTENT WITH CONTINUED SCOPE ADVANCEMENT DURING BUCKLING AND PROLAPSE, RESULTING IN EXCESSIVE MECHANICAL FORCE APPLIED TO THE AIRWAY WALL. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE GALAXY SYSTEM, STATING THAT THE BLEEDING ORIGINATED POSTERIOR TO THE ENDOTRACHEAL TUBE AND COULD NOT BE LOCALIZED TO A SPECIFIC LUNG LOBE. VIDEO REVIEW SUPPORTS THIS ASSESSMENT, AS BLEEDING OCCURRED IN THE CONTEXT OF SEVERE SCOPE BUCKLING AND AIRWAY CONTACT RATHER THAN UNINTENDED SYSTEM MOTION OR DEVICE MALFUNCTION. THIS COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSIONS: BLEEDING WAS REPORTED DURING A GALAXY-ASSISTED BIOPSY PROCEDURE FOR A LESION IN THE LEFT LOWER LOBE. WHILE NAVIGATING, THE USER PERCEIVED REVERSED SCOPE CONTROLS AND OBSERVED SCOPE PROLAPSE, PROMPTING A DECISION TO EXCHANGE THE SCOPE. DURING THE SCOPE CHANGE, MILD BLEEDING WAS NOTED. APPROXIMATELY 50 CC OF BLOOD WAS SUCTIONED, AND THROMBIN WAS ADMINISTERED TO ACHIEVE HEMOSTASIS. THE BLEEDING WAS SUCCESSFULLY CONTROLLED, THE SCOPE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE PATIENT WAS ADMITTED FOR NON-MEDICAL REASONS RELATED TO TRANSPORTATION AVAILABILITY. DEVICE ISSUES OF SCOPE PROLAPSE AND PERCEIVED REVERSE MOVEMENT WERE REPORTED, AND ONE USE ERROR WAS IDENTIFIED.

    Description of Event or Problem · 0

    DURING A GALAXY-ASSISTED BIOPSY PROCEDURE FOR A LEFT LOWER LOBE LESION, THE PHYSICIAN REPORTED DIFFICULTY DRIVING THE BRONCHOSCOPE AND PERCEIVED THAT THE CONTROLS WERE REVERSED. THE CONTROLLER WAS EXCHANGED; HOWEVER, THE ISSUE PERSISTED. A FLUOROSCOPIC IMAGE OBTAINED DURING TROUBLESHOOTING DEMONSTRATED SCOPE PROLAPSE. WHILE PREPARING TO EXCHANGE THE SCOPE, MILD BLEEDING WAS OBSERVED. THE BRONCHOSCOPE WAS REMOVED, AND THE BLEEDING WAS CONTROLLED WITH THROMBIN ADMINISTRATION AND SUCTIONING. APPROXIMATELY 50 CC OF BLOOD LOSS WAS REPORTED. A NEW BRONCHOSCOPE WAS INTRODUCED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. NO ADDITIONAL MEDICAL COMPLICATIONS OR INTERVENTIONS WERE REQUIRED. ALTHOUGH THE PATIENT WAS ADMITTED, THIS WAS REPORTED TO BE DUE TO TRANSPORTATION UNAVAILABILITY RATHER THAN MEDICAL NECESSITY. THE PATIENT HAS A HISTORY OF COPD. DEVICE ISSUES OF REVERSED CONTROLS AND SCOPE PROLAPSE WERE INITIALLY REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344870 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL GALB-001 2025051401

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention