BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 23762316 · Received December 9, 2025

    Report

    Report Number
    3021325-2025-00066
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    July 5, 2024
    Report Date
    December 8, 2025
    Manufacturer
    NOAH MEDICAL CORP
    Product Code
    EOQ
    UDI-DI
    00850048825048
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCOPE WAS NOT RETURNED FOR INVESTIGATION. THE SPECIFIC SCOPE USED IN THIS CASE COULD NOT BE CONFIRMED, AND A COMPLETE DEVICE-SPECIFIC RECORD REVIEW COULD NOT BE PERFORMED. VIDEO REVIEW IDENTIFIED NO USE ERRORS AND CONFIRMED THAT THE LESION WAS LOCATED CLOSE TO THE PLEURA. PARENCHYMA-LIKE TISSUE BRIEFLY APPEARED IN THE CAMERA VIEW, WHICH MAY INDICATE PARENCHYMAL BREAKTHROUGH AS THE PHYSICIAN INTENTIONALLY ADVANCED TO ACCESS THE LESION. THE PHYSICIAN PROCEEDED WITH THE PROCEDURE AND SUBSEQUENT BIOPSIES, WITH NO DEVIATIONS FROM EXPECTED WORKFLOW NOTED. THE PHYSICIAN DID NOT ATTRIBUTE THE PNEUMOTHORAX TO THE GALAXY SYSTEM AND STATED THAT THE INJURY WAS DUE TO THE NATURE AND ANATOMY OF THE LESION. GIVEN THE LESION'S PLEURAL LOCATION, CYSTIC CHARACTERISTICS, AND THE TIMING OF SYMPTOM DEVELOPMENT, THE EVENT IS CONSISTENT WITH THE KNOWN INHERENT RISKS ASSOCIATED WITH BRONCHOSCOPY AND TRANSBRONCHIAL BIOPSY.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE AND WAS DISCHARGED HOME THE SAME DAY WITHOUT COMPLICATIONS. THREE DAYS LATER, THE PATIENT REPORTED WORSENING CHEST PAIN AND WAS INSTRUCTED TO PRESENT TO THE EMERGENCY DEPARTMENT, WHERE A SMALL RIGHT-SIDED PNEUMOTHORAX WAS IDENTIFIED. A CHEST TUBE WAS PLACED AND REMAINED IN PLACE FOR 48 HOURS. THE PATIENT WAS DISCHARGED HOME AFTER 72 HOURS AND REPORTED TO BE IN GOOD CONDITION. NO MALFUNCTIONS WERE REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2721931 GALAXY SYSTEM GALAXY SYSTEM, PRODUCT GAL-001 EOQ NOAH MEDICAL CORP 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Hospitalization| R