BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23864584 · Received December 22, 2025

    Report

    Report Number
    3021325287-2025-00086
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    July 25, 2025
    Report Date
    December 22, 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. THE SCOPE WAS NOT RETURNED FOR INVESTIGATION AS IT WAS DISCARDED; MANUFACTURING RECORDS CONFIRMED THE DEVICE PASSED FINAL QA/QC PRIOR TO RELEASE. VIDEO REVIEW IDENTIFIED NO USE ERRORS OR SYSTEM MALFUNCTIONS. THE PHYSICIAN INTENTIONALLY BREACHED THE PARENCHYMA TO IMPROVE ACCESS TO A PERIPHERAL LESION, AND REBUS AND BIOPSY TOOLS WERE ADVANCED UNDER DELIBERATE CONTROL WITHOUT EXCESSIVE BLEEDING OR ABRUPT SCOPE MOVEMENT. LATER IN THE PROCEDURE, PATIENT MOVEMENT CONSISTENT WITH COUGHING WAS OBSERVED AS ANESTHESIA WORE OFF, AT WHICH TIME NO TOOLS WERE EXTENDED AND NO VISUAL SIGNS OF ACUTE INJURY WERE PRESENT. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM AND STATED IT WAS MOST LIKELY RELATED TO PATIENT COUGHING. VIDEO REVIEW SUPPORTS THIS ASSESSMENT, AND THE PNEUMOTHORAX IS MOST CONSISTENT WITH CUMULATIVE TISSUE STRESS FROM BIOPSY COMBINED WITH PATIENT COUGHING RATHER THAN DEVICE-RELATED FACTORS.

    Description of Event or Problem · 0

    A PNEUMOTHORAX WAS IDENTIFIED FOLLOWING A GALAXY-ASSISTED BIOPSY PROCEDURE PERFORMED FOR A LESION IN THE LEFT UPPER LOBE. A CHEST TUBE WAS INSERTED, AND THE PATIENT WAS ADMITTED FOR OVERNIGHT OBSERVATION BEFORE BEING DISCHARGED THE FOLLOWING DAY. NO FURTHER COMPLICATIONS OR INTERVENTIONS WERE REPORTED. NO MALFUNCTIONS WERE REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874696 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL CORP GALB-001 2025052901

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention| H