BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23097396 · Received September 19, 2025

    Report

    Report Number
    3021325287-2025-00029
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 18, 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

    FOLLOWING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. AS PART OF THE MEDICAL MANAGEMENT, A CHEST TUBE WAS INSERTED, AND THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT WAS DISCHARGED TWO DAYS LATER. NO DEVICE MALFUNCTIONS WERE REPORTED DURING THE PROCEDURE, AND THE PHYSICIAN ATTRIBUTED THE INJURY TO THE FORCEPS BIOPSY RATHER THAN THE USE OF THE GALAXY DEVICE. AN INVESTIGATION WAS CONDUCTED THROUGH LOG AND VIDEO ANALYSIS OF THE PROCEDURE BY A CLINICAL ENGINEER. THE REVIEW CONFIRMED THAT NO MALFUNCTION OF THE NOAH DEVICE CAUSED OR CONTRIBUTED TO THE INJURY. INSTEAD, THE FINDINGS INDICATE THAT THE PNEUMOTHORAX RESULTED FROM USER ERROR. THE VIDEO ANALYSIS SHOWED THAT THE BIOPSY TOOLS, INCLUDING THE FORCEPS AND NEEDLE, WERE ADVANCED BEYOND THE AUGMENTED FLUORO OVERLAY CIRCLE, AND LIVE FLUOROSCOPY WAS NOT USED FOR GUIDANCE DURING INSERTION. FURTHERMORE, THE LESION WAS LOCATED PERIPHERALLY AND IN CLOSE PROXIMITY TO THE FISSURES, FACTORS THAT INCREASED THE RISK OF PNEUMOTHORAX DURING TOOL INSERTION.

    Description of Event or Problem · 0

    FOLLOWING A NOAH GALAXY DEVICE-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT EXPERIENCED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED AS AN INTERVENTION, AND THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY DISCHARGED ON (B)(6) 2025. THE PHYSICIAN DID NOT ATTRIBUTE THE INJURY TO THE USE OF THE GALAXY SYSTEM BUT RATHER TO THE FORCEPS BIOPSY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723254 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Hospitalization| R