BEUDAMED
    FDA Adverse Event Death Summary report: N

    GALAXY SYSTEM

    MDR report key: 22755985 · Received August 8, 2025

    Report

    Report Number
    3021325287-2025-00017
    Event Type
    Death
    Date Received
    August 8, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 8, 2025
    Manufacturer
    NOAH MEDICAL INC.
    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. FAILURE ANALYSIS OF THE SCOPE COULD NOT BE PERFORMED AS THE SCOPE WAS DISCARDED. FINAL INSPECTION AND TEST RECORDS CONFIRM THAT THE SCOPE USED IN THE CASE PASSED EACH TEST. REVIEW OF THE PROCEDURAL VIDEO SHOWS THAT AT 3:26, THE SCOPE WAS ADVANCED INTO THE LUNG PARENCHYMA, PRECIPITATING BLEEDING IN THE RIGHT MIDDLE LOBE AT 4:22. IRRIGATION CONTROLLED THE INITIAL BLEED AT 5:53, BUT BY 12:35 A PARENCHYMAL TEAR WAS VISIBLE UPON SCOPE WITHDRAWAL. BLEEDING RECURRED IN THE DISTAL AIRWAY AT 27:38, MANAGED AGAIN WITH IRRIGATION AT 28:14. DESPITE PERSISTENT BLEEDING OBSERVED AT 38:50, THE USER PROCEEDED WITH A FINAL BIOPSY AT 43:03, THEN WEDGED THE SCOPE TO TAMPONADE THE BLEED BEFORE CONCLUDING THE PROCEDURE. NO USE ERRORS WERE IDENTIFIED. THE PHYSICIAN WAS UNABLE TO DETERMINE A DEFINITIVE CAUSE OF INJURY DUE TO THE VOLUME OF BLOOD AND DID NOT ATTRIBUTE THE EVENT TO THE GALAXY SYSTEM. EFFORTS TO OBTAIN AN AUTOPSY REPORT, DEFINITIVE CAUSE OF DEATH AND TO CLARIFY DNR STATUS ARE ONGOING. IN CONCLUSION, IT IS UNLIKELY THAT THE GALAXY SYSTEM CAUSED OR CONTRIBUTED TO THE INJURY OR THE PATIENT'S DEATH, THE DEATH IS LIKELY A RESULT OF THE PATIENT'S CONDITION. NO MALFUNCTIONS WERE REPORTED AND NO USE ERRORS WERE IDENTIFIED.

    Description of Event or Problem · 0

    A PATIENT'S DEATH WAS REPORTED 2 HOURS AFTER UNDERGOING A GALAXY SYSTEM-ASSISTED BIOPSY OF A RIGHT LOWER LOBE LESION. WITHIN FIVE TO TEN MINUTES POST-PROCEDURE, SIGNIFICANT BLEEDING WAS NOTED AND APPROXIMATELY 100 ML OF BLOOD WAS SUCTIONED IN THE POST-ANESTHESIA CARE UNIT. AN EMERGENCY BRONCHOSCOPY FAILED TO CONTROL THE BLEEDING, AND THE PATIENT CODED THREE TIMES BEFORE PASSING AWAY. THE PATIENT HAD NO KNOWN COAGULOPATHIES OR ANTICOAGULANT THERAPY BUT DID HAVE A HISTORY OF CANCER. NO DEVICE MALFUNCTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2162371 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL INC. 2025042301

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Death