BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 21370348 · Received February 12, 2025

    Report

    Report Number
    3021325287-2025-00005
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    September 16, 2024
    Report Date
    February 12, 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

    ON (B)(6) 2024, FOLLOWING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE PACU, WHERE THE PHYSICIAN IDENTIFIED A PNEUMOTHORAX. AS A RESULT, THE PATIENT WAS HOSPITALIZED AND MONITORED BY THE MEDICAL STAFF. NO CHEST TUBE INTERVENTION WAS REQUIRED. NO MALFUNCTIONS OF THE NOAH GALAXY DEVICE WERE REPORTED DURING THE PROCEDURE. THE PHYSICIAN DOES NOT ATTRIBUTE THE INJURY TO THE DEVICE BUT RATHER TO A COMPLICATION OF THE BIOPSY PROCEDURE. NOTABLY, THE PATIENT ALSO HAD A HISTORY OF PNEUMOTHORAX. A CLINICAL ENGINEER REVIEWED THE PROCEDURE VIDEO LOG, AND THE INVESTIGATION FOUND NO MALFUNCTIONS OR USER ERRORS ASSOCIATED WITH THE GALAXY DEVICE. THIS CASE IS BEING REPORTED RETROSPECTIVELY TO DOCUMENT THE PNEUMOTHORAX.

    Description of Event or Problem · 0

    ON (B)(6) 2024, FOLLOWING A GALAXY-ASSISTED PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE PACU, WHERE THE PHYSICIAN IDENTIFIED A PNEUMOTHORAX. AS A RESULT, THE PATIENT WAS HOSPITALIZED FOR OBSERVATION; HOWEVER, NO CHEST TUBE INTERVENTION WAS REQUIRED. THE PHYSICIAN DOES NOT ATTRIBUTE THE INJURY TO THE USE OF THE NOAH GALAXY DEVICE BUT INSTEAD CONSIDERS IT A COMPLICATION OF THE BIOPSY PROCEDURE. NO MALFUNCTIONS OR IRREGULARITIES WERE REPORTED WITH THE GALAXY DEVICE, WHICH FUNCTIONED AS EXPECTED THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984598 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Hospitalization