BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23762418 · Received December 9, 2025

    Report

    Report Number
    3021325-2025-00068
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    March 4, 2024
    Report Date
    December 8, 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

    THIS CASE IS NOT BEING REPORTED DUE TO POTENTIAL SAFETY ISSUES BUT AS A RESULT OF REPORTING OF ALL SERIOUS ADVERSE EVENTS. THE SCOPE WAS NOT RETURNED FOR INVESTIGATION. MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE SPECIFIC SCOPE USED IN THIS CASE COULD NOT BE IDENTIFIED. VIDEO REVIEW COULD NOT BE PERFORMED DUE TO LOG UNAVAILABILITY. THE PHYSICIAN DID NOT ATTRIBUTE THE CHEST INFECTION TO THE GALAXY SYSTEM. BASED ON ALL AVAILABLE INFORMATION, INCLUDING THE PATIENT'S MEDICAL HISTORY AND ABSENCE OF DEVICE-RELATED CONCERNS; THE INJURY IS MOST CONSISTENT WITH THE KNOWN INHERENT RISKS OF BRONCHOSCOPY.

    Description of Event or Problem · 0

    A CHEST INFECTION WAS REPORTED SEVERAL DAYS AFTER A GALAXY-ASSISTED BIOPSY PROCEDURE FOR A CLINICAL TRIAL. THE PATIENT REQUIRED HOSPITAL ADMISSION FOR TREATMENT AND WAS DISCHARGED A SHORT TIME LATER WITH FULL RECOVERY AND NO FURTHER COMPLICATIONS. THE PATIENT IS A FORMER SMOKER WITH A HISTORY OF MALIGNANT CANCER OF THE LUNGS AND RECTUM. NO MALFUNCTIONS WERE REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604063 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE GALB-001 EOQ NOAH MEDICAL CORP GALB-001 2023101301

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R