BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 22242395 · Received June 17, 2025

    Report

    Report Number
    3021325287-2025-00025
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    May 23, 2025
    Report Date
    June 15, 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

    DURING A BRONCHOSCOPY PROCEDURE ASSISTED BY THE NOAH GALAXY SYSTEM, THE PATIENT EXPERIENCED A PNEUMOTHORAX. A CHEST TUBE WAS INSERTED AS AN INTERVENTION. A DEVICE MALFUNCTION RELATED TO DIFFICULTY LOCATING THE LESION WAS REPORTED DURING THE PROCEDURE. HOWEVER, THIS MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. AN INITIAL INVESTIGATION BY AN ENGINEER DETERMINED THAT THE LESION WAS NOT VISIBLE ON THE CT SCAN ITSELF, WHICH EXPLAINS WHY IT WAS DIFFICULT TO VISUALIZE USING TOMO. ADDITIONALLY, THE PHYSICIAN DOES NOT ATTRIBUTE THE PNEUMOTHORAX TO THE USE OF THE GALAXY DEVICE. UPON REVIEW OF THE PROCEDURAL LOG AND VIDEO BY A CLINICAL ENGINEER, IT WAS OBSERVED THAT THE BIOPSY TOOL WAS ADVANCED TOO FAR, WHICH MAY HAVE CONTRIBUTED TO THE OCCURRENCE OF THE INJURY. THIS CASE IS BEING REPORTED TO DOCUMENT THE OCCURRENCE OF PNEUMOTHORAX DURING THE PROCEDURE.

    Description of Event or Problem · 0

    DURING A GALAXY-ASSISTED BRONCHOSCOPY, THE PATIENT EXPERIENCED A PNEUMOTHORAX. IN RESPONSE, A CHEST TUBE WAS PLACED, AND THE PATIENT WAS DISCHARGED THE SAME DAY FOLLOWING ITS REMOVAL. THE PHYSICIAN REPORTED DIFFICULTY LOCATING THE LESION DURING THE PROCEDURE, INITIALLY SUSPECTED TO BE A DEVICE MALFUNCTION. HOWEVER, PRELIMINARY INVESTIGATION BY THE ENGINEER REVEALED THAT THE LESION WAS NOT VISIBLE ON THE CT SCAN ITSELF, WHICH ACCOUNTS FOR ITS ABSENCE ON TOMO. HOWEVER, THIS ISSUE DID NOT CAUSE OR CONTRIBUTE TO THE PNEUMOTHORAX. THE PHYSICIAN DOES NOT ATTRIBUTE THE INJURY TO THE USE OF THE NOAH MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38967 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention