BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23562755 · Received November 14, 2025

    Report

    Report Number
    3021325287-2025-00054
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    April 22, 2024
    Report Date
    November 14, 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

    SYSTEM AND BRONCHOSCOPE MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. THE SCOPE WAS NOT RETURNED FOR INVESTIGATION, AS IT WAS DISCARDED. MANUFACTURING RECORDS CONFIRMED IT PASSED THE FINAL QA/QC CHECK PRIOR TO RELEASE. VIDEO REVIEW SHOWED NO MALFUNCTIONS OR USE ERRORS. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM AND DID NOT SPECIFY A CAUSE. THE LESION WAS LOCATED IN THE RIGHT MIDDLE LOBE, WHILE THE PNEUMOTHORAX OCCURRED ELSEWHERE IN THE RIGHT LUNG. THE PROCEDURE INCLUDED AIRWAY INSPECTION, GALAXY-ASSISTED BIOPSY, AND EBUS, WITH THE INJURY IDENTIFIED POST-OPERATIVELY. BASED ON THE AVAILABLE INFORMATION, THE EVENT IS CONSISTENT WITH THE KNOWN INHERENT RISKS OF BRONCHOSCOPY AND BIOPSY PROCEDURES. THIS COMPLAINT IS REPORTED DUE TO THE FOLLOWING CONCLUSIONS: A PNEUMOTHORAX WAS IDENTIFIED POST-OPERATIVELY FOLLOWING A GALAXY-ASSISTED BIOPSY PROCEDURE. A CHEST TUBE WAS INSERTED TO TREAT THE INJURY. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM. NO MALFUNCTIONS WERE REPORTED, AND NO USE ERRORS WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE PNEUMOTHORAX WAS IDENTIFIED POST-PROCEDURE, LOCATED IN THE RIGHT LUNG, WHILE THE LESION WAS IN THE RIGHT MIDDLE LOBE (RML). A CHEST TUBE WAS INSERTED, AND THE PATIENT REMAINED STABLE. NO MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2790266 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 2024011601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention