BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23804016 · Received December 15, 2025

    Report

    Report Number
    3021325287-2025-00069
    Event Type
    Injury
    Date Received
    December 15, 2025
    Date of Event
    September 11, 2024
    Report Date
    December 12, 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

    THE SCOPE WAS NOT RETURNED FOR INVESTIGATION, BUT MANUFACTURING RECORDS CONFIRMED IT PASSED FINAL QA/QC. VIDEO REVIEW IDENTIFIED NO SYSTEM MALFUNCTIONS OR USE ERRORS. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE GALAXY SYSTEM, STATING IT WAS RELATED TO BIOPSY ACTIVITY. VIDEO REVIEW SUPPORTS THIS CONCLUSION, AS BLEEDING ONSET AND ESCALATION CORRESPONDED DIRECTLY WITH SAMPLING AND NO DEVICE-RELATED ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 0

    AFTER COMPLETING SAMPLING OF A RIGHT UPPER LOBE (RUL) LESION, THE PHYSICIAN BEGAN WITHDRAWING THE GALAXY BRONCHOSCOPE BUT WAS UNABLE TO VISUALIZE THE AIRWAY BECAUSE THE CAMERA VIEW HAD BECOME COMPLETELY RED. A FLUOROSCOPY IMAGE CONFIRMED THE SCOPE WAS ALREADY NEAR THE TRACHEA. THE GALAXY SCOPE WAS RAPIDLY REMOVED, AND A THERAPEUTIC SCOPE WAS CALLED FOR. WHILE THE THERAPEUTIC SCOPE WAS BEING PREPARED, BLOOD WAS OBSERVED RISING INTO THE ENDOTRACHEAL TUBE (ETT). THE PHYSICIAN IMMEDIATELY BEGAN SUCTIONING AND WAS ABLE TO RE-ENTER THE RUL, WEDGING THE BRONCHOSCOPE TO TAMPONADE THE BLEEDING. THE PATIENT WAS PLACED IN THE RIGHT-SIDE-DOWN POSITION, ICE-COLD SALINE WAS INSTILLED MULTIPLE TIMES, AND A FOGARTY BALLOON WAS ALSO USED FOR TAMPONADE. AFTER SEVERAL MINUTES, BLEEDING STOPPED, AND THE AIRWAYS WERE SUCTIONED CLEAR. THE PATIENT WAS EXTUBATED, TAKEN TO PACU IN STABLE CONDITION, RECEIVED A CHEST X-RAY, AND WAS LATER DISCHARGED HOME. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789523 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL CORP GALB-001 2024072401

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention