BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 20140766 · Received September 4, 2024

    Report

    Report Number
    3021325287-2024-00007
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 4, 2024
    Manufacturer
    NOAH MEDICAL
    Product Code
    EOQ
    UDI-DI
    00850048825000
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, A PNEUMOTHORAX INCIDENT WAS REPORTED IN A PATIENT. FOLLOWING THE ADVERSE EVENT, AN INVESTIGATION WAS CONDUCTED TO DETERMINE IF ANY MALFUNCTIONS OR MANUFACTURER-RELATED FACTORS COULD HAVE CONTRIBUTED TO THE INCIDENT. THE USER NOTED A MALFUNCTION INVOLVING EM SIGNAL LOSS DURING THE PROCEDURE, WHICH WAS OBSERVED AFTER THE TILT SWEEP. EM SIGNAL LOSS LASTED FOR 54 SECONDS. IT MAY HAVE BEEN DUE TO THE INTERFERENCE FROM C-ARM, SAMPLING BIOPSY TOOL, OR AN UNKNOWN ENVIRONMENTAL FACTOR. IT DOES NOT APPEAR TO HAVE CAUSED THE ADVERSE EVENT AND HENCE THE INVESTIGATION WAS BROADENED TO ASSESS OTHER POSSIBLE CAUSES. THE RETURNED BRONCHOSCOPE DEVICE WAS EVALUATED IN-HOUSE TO REPLICATE THE REPORTED ISSUE. THE STAFF ENGINEER WAS UNABLE TO REPLICATE THE ISSUE AND FOUND THE BRONCHOSCOPE TO BE FUNCTIONING AS EXPECTED. ADDITIONALLY, THE INVESTIGATION CONCLUDED THAT THERE WAS NO UNINTENDED MOTION OF THE IDM. THE ENGINEER DID NOT FIND ANY SCOPE MOTION LIKE ARTICULATION/RETRACTION DURING SAMPLING. IN CONCLUSION, THE GALAXY SYSTEM FUNCTIONED AS EXPECTED. NO ROOT CAUSE THAT COULD HAVE CAUSED/CONTRIBUTED TO THE EVENT WAS FOUND. THE PHYSICIAN ATTRIBUTED THE PNEUMOTHORAX EVENT TO THE LESION LOCATION AND PARTIALLY TO THE USE OF NOAH'S GALAXY SYSTEM. IT IS ACKNOWLEDGED THAT THE POTENTIAL FOR A PNEUMOTHORAX IS AN INHERENT RISK ASSOCIATED WITH BRONCHOSCOPY PROCEDURES, AND THIS RISK IS DULY DOCUMENTED IN NOAH MEDICAL'S RISK FILE. ONGOING TRACKING AND TRENDING OF SUCH INCIDENTS WILL BE MAINTAINED TO FACILITATE CONTINUOUS IMPROVEMENT AND RISK MANAGEMENT STRATEGIES.

    Description of Event or Problem · 0

    DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, A PNEUMOTHORAX WAS REPORTED IN THE PATIENT. ALTHOUGH THE PHYSICIAN NOTED EM SIGNAL LOSS DURING THE PROCEDURE, AN INVESTIGATION OF THE LOGS AND AN EVALUATION OF THE RETURNED DEVICE CONCLUDED THAT THE NOAH MEDICAL DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. HOWEVER, THE PHYSICIAN PARTIALLY ATTRIBUTED THE INJURY TO THE GALAXY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237616 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL 2024061801 00850048825000

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization