BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23831454 · Received December 17, 2025

    Report

    Report Number
    3021325287-2025-00077
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    February 21, 2025
    Report Date
    December 17, 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 RETURNED FOR ANALYSIS, AND MANUFACTURING RECORDS CONFIRMED IT PASSED FINAL QA/QC RELEASE. INVESTIGATION IDENTIFIED DEFORMATION OF THE PULL WIRES NEAR THE TIP THAT NARROWED THE WORKING CHANNEL AND IMPEDED TOOL PASSAGE; THIS CONDITION OCCURRED PRIOR TO THE BLEEDING EVENT AND DID NOT CONTRIBUTE TO THE INJURY. A SEPARATE LOST-VIDEO ISSUE WAS TRACED TO CAM/LED CABLE DAMAGE FROM BENDING-SECTION CONTACT DURING ARTICULATION, RESULTING IN A TRANSIENT LOSS OF ILLUMINATION; THIS OCCURRED AFTER THE BLEEDING AND DID NOT CONTRIBUTE TO THE EVENT. VIDEO REVIEW IDENTIFIED NO USE ERRORS. BLEEDING WAS OBSERVED IMMEDIATELY FOLLOWING NEEDLE BIOPSY OF A LARGE, HIGHLY VASCULAR LESION, AFTER WHICH THE OPERATOR APPROPRIATELY TRANSITIONED TO A THERAPEUTIC BRONCHOSCOPE TO ACHIEVE HEMOSTASIS. NO DEVIATIONS FROM EXPECTED GALAXY SYSTEM OPERATION WERE OBSERVED. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE GALAXY SYSTEM, STATING IT WAS DUE TO FNA OF A VASCULAR MASS; VIDEO REVIEW SUPPORTS THIS ASSESSMENT.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, BLEEDING WAS OBSERVED AFTER BIOPSYING A LARGE, HIGHLY VASCULAR LESION IN THE RIGHT UPPER LOBE. THE GALAXY SCOPE WAS RETRACTED, AND A THERAPEUTIC BRONCHOSCOPE WAS INSERTED TO SUCTION BLOOD MORE EFFECTIVELY AND WEDGE TO PROMOTE CLOT FORMATION. THERE WERE NO REPORTS OF REPEATED ATTEMPTS TO CONTROL THE BLEEDING. THE PHYSICIAN CONTINUED WITH THE CASE AND PROCEEDED WITH ADDITIONAL SAMPLING. NO FURTHER COMPLICATIONS OR INTERVENTIONS WERE REPORTED. MALFUNCTIONS OF "BIOPSY TOOL NOT PASSING THROUGH" AND "LOST VIDEO" WERE REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016393 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL CORP GALB-001 2024102901

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention