BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23562752 · Received November 14, 2025

    Report

    Report Number
    3021325287-2025-00051
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    April 15, 2024
    Report Date
    November 14, 2025
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Product Problem
    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 DISCARDED AND NOT AVAILABLE FOR INVESTIGATION; MANUFACTURING RECORDS FOR SCOPE USED IN THE CASE CONFIRMED IT PASSED THE FINAL QA/QC CHECK. THE REPORTED DIFFICULTY ATTACHING THE SCOPE OCCURRED AT SETUP, DID NOT RECUR, AND IS CONSIDERED AN ISOLATED ISSUE UNRELATED TO THE PNEUMOTHORAX. VIDEO REVIEW COULD NOT BE PERFORMED DUE TO MISSING LOGS. THE PHYSICIAN DID NOT ATTRIBUTE THE SMALL FISSURE-RELATED PNEUMOTHORAX TO THE GALAXY SYSTEM, AND ITS CHARACTERISTICS ARE CONSISTENT WITH KNOWN PROCEDURAL RISKS OF BRONCHOSCOPY NEAR PLEURAL/FISSURAL SURFACES. THIS COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A SMALL PNEUMOTHORAX ALONG THE FISSURE WAS IDENTIFIED FOLLOWING A GALAXY-ASSISTED BIOPSY PROCEDURE. ALTHOUGH A CHEST TUBE WAS NOT REQUIRED, THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. THE PHYSICIAN DID NOT ATTRIBUTE THE INJURY TO THE GALAXY SYSTEM. A MALFUNCTION RELATED TO DIFFICULTY ATTACHING THE SCOPE AT THE START OF THE CASE WAS REPORTED.

    Description of Event or Problem · 0

    A SMALL PNEUMOTHORAX WAS IDENTIFIED ALONG THE FISSURE FOLLOWING A GALAXY-ASSISTED BIOPSY PROCEDURE. THE PNEUMOTHORAX DID NOT REQUIRE CHEST TUBE INSERTION; THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION AND DISCHARGED THE NEXT DAY. A MALFUNCTION OF DIFFICULTY ATTACHING THE SCOPE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790263 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 2024021402

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female Hospitalization