BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 25243759 · Received May 21, 2026

    Report

    Report Number
    3021325287-2026-00017
    Event Type
    Injury
    Date Received
    May 21, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 21, 2026
    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

    ADDITIONAL INFORMATION PROVIDED BY THE NOAH CLINICAL REPRESENTATIVE CONFIRMED THAT THE PNEUMOTHORAX WAS IDENTIFIED AFTER THE PROCEDURE DUE TO PATIENT OXYGEN DESATURATION AND WAS CONFIRMED BY CHEST X-RAY. THE CHEST TUBE WAS REMOVED ONE DAY AFTER THE PROCEDURE, AND THE PATIENT WAS DISCHARGED THREE DAYS AFTER THE PROCEDURE IN GOOD CONDITION. THE PHYSICIAN ATTRIBUTED THE PNEUMOTHORAX TO THE BIOPSY AND BELIEVED THE INJURY WAS CAUSED BY BIOPSY THROUGH THE PLEURA. NO GALAXY SYSTEM MALFUNCTIONS WERE OBSERVED OR REPORTED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED. THE BRONCHOSCOPE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. SYSTEM MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS EVENT. THE BRONCHOSCOPE WAS NOT RETURNED FOR INVESTIGATION AS IT WAS DISCARDED. MANUFACTURING RECORDS CONFIRMED THE BRONCHOSCOPE PASSED FINAL INSPECTION PRIOR TO RELEASE, WITH NO ABNORMALITIES IDENTIFIED. VIDEO REVIEW DEMONSTRATED THAT THE GALAXY SYSTEM FUNCTIONED AS INTENDED THROUGHOUT THE PROCEDURE, WITH NO EVIDENCE OF SYSTEM MALFUNCTION OR ABNORMAL SYSTEM BEHAVIOR. MULTIPLE NEEDLE AND FORCEPS BIOPSY PASSES WERE PERFORMED NEAR THE PLEURAL BOUNDARY. NO EVIDENCE OR ALLEGATION OF GALAXY SYSTEM MALFUNCTION CONTRIBUTING TO THE REPORTED EVENT WAS IDENTIFIED. THE PHYSICIAN ATTRIBUTED THE INJURY TO BIOPSY THROUGH THE PLEURA. THE REPORTED PNEUMOTHORAX IS MOST CONSISTENT WITH PROCEDURAL INJURY RELATED TO BIOPSY ACTIVITY THROUGH OR NEAR THE PLEURA. THIS MDR HAS BEEN SUBMITTED BECAUSE A PNEUMOTHORAX REQUIRING CHEST TUBE PLACEMENT AND MICU ADMISSION OCCURRED FOLLOWING A GALAXY-ASSISTED BRONCHOSCOPY BIOPSY PROCEDURE. INVESTIGATION DEMONSTRATED THAT THE GALAXY SYSTEM FUNCTIONED AS INTENDED THROUGHOUT THE PROCEDURE, WITH NO EVIDENCE OF DEVICE MALFUNCTION OR USE ERROR CONTRIBUTING TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 69 YEAR OLD MALE, UNDERWENT A GALAXY-ASSISTED BIOPSY PROCEDURE FOR A LESION IN THE LEFT UPPER LOBE MEASURING 2.8CM. THERE WERE NO REPORTED MALFUNCTIONS. AFTER THE GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE WAS COMPLETED, THE PATIENT EXPERIENCED OXYGEN DESATURATION AND WAS FOUND TO HAVE A PNEUMOTHORAX. A CHEST TUBE WAS PLACED, AND THE PATIENT WAS ADMITTED TO THE MICU FOR OBSERVATION. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209216 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE EOQ NOAH MEDICAL CORP. 2025111001

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| R EBUS