BEUDAMED
    FDA Adverse Event Death Summary report: N

    GALAXY SYSTEM

    MDR report key: 22075042 · Received May 22, 2025

    Report

    Report Number
    3021325287-2025-00012
    Event Type
    Death
    Date Received
    May 22, 2025
    Date of Event
    April 28, 2025
    Report Date
    September 4, 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. REVIEW OF THE VIDEO LOGS REVEALED BLOOD OBSERVED DURING REGISTRATION AT 0:44. AT 00:56, BLEEDING AND TISSUE TRAUMA WERE NOTED IN THE LEFT LOWER LOBE AIRWAYS, INDICATING THAT THESE ISSUES WERE PRESENT IN THE PATIENT PRIOR TO THE GALAXY PROCEDURE. THE USER CONTINUED NAVIGATION, WITH BLEEDING OBSERVED IN THE SAME AREA AS THE TARGET LESION. THE USER WAS ABLE TO COMPLETE ALL BIOPSIES AND CONCLUDE THE PROCEDURE. IT WAS CONFIRMED BY A NOAH REPRESENTATIVE ON-SITE THAT THE EXCESSIVE BLEEDING WAS FIRST IDENTIFIED BY THE USER DURING STANDARD BRONCHOALVEOLAR LAVAGE (BAL) FOLLOWING THE GALAXY PROCEDURE. NO USE ERRORS WERE IDENTIFIED. THE SCOPE PASSED ALL THE MANUFACTURING PROCESS AND FINAL INSPECTIONS. THE PRODUCT WAS MANUFACTURED AS DESIGNED. FAILURE ANALYSIS OF THE SCOPE COULD NOT BE PERFORMED AS THE SCOPE WAS DISCARDED. THE PHYSICIAN DOES NOT ATTRIBUTE THE DEATH TO THE GALAXY SYSTEM, INSTEAD STATING THAT IT WAS CAUSED BY BLEEDING FROM THE BIOPSY. THE PATIENT'S PRE-EXISTING CONDITION CONTRIBUTED TO AN INCREASED RISK. THIS CASE IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: A PATIENT'S DEATH OCCURRED FOLLOWING A GALAXY-ASSISTED BIOPSY PROCEDURE, AND STANDARD CODE PROTOCOLS WERE INITIATED. THE PHYSICIAN DOES NOT ATTRIBUTE THE DEATH TO THE GALAXY SYSTEM, INSTEAD STATING THAT IT WAS CAUSED BY BLEEDING FROM THE BIOPSY. ADDITIONALLY, THE PATIENT HAD A PRE-EXISTING CHEST TUBE FROM A HEALED PNEUMOTHORAX DUE TO A NECROTIC LESION IN THE LEFT LUNG PRIOR TO THE PROCEDURE AND WAS ALSO UNDERGOING CHEMOTHERAPY. NO MALFUNCTIONS WERE REPORTED.

    Additional Manufacturer Narrative · 0

    SYSTEM AND BRONCHOSCOPE MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED WITH THIS CASE. REVIEW OF THE VIDEO LOGS REVEALED BLOOD OBSERVED DURING REGISTRATION AT 0:44. AT 00:56, BLEEDING AND TISSUE TRAUMA WERE NOTED IN THE LEFT LOWER LOBE AIRWAYS, INDICATING THAT THESE ISSUES WERE PRESENT IN THE PATIENT PRIOR TO THE GALAXY PROCEDURE. THE USER CONTINUED NAVIGATION, WITH BLEEDING OBSERVED IN THE SAME AREA AS THE TARGET LESION. THE USER WAS ABLE TO COMPLETE ALL BIOPSIES AND CONCLUDE THE PROCEDURE. IT WAS CONFIRMED BY A NOAH REPRESENTATIVE ON-SITE THAT THE EXCESSIVE BLEEDING WAS FIRST IDENTIFIED BY THE USER DURING STANDARD BRONCHOALVEOLAR LAVAGE (BAL) FOLLOWING THE GALAXY PROCEDURE. NO USE ERRORS WERE IDENTIFIED. THE SCOPE PASSED ALL THE MANUFACTURING PROCESS AND FINAL INSPECTIONS. THE PRODUCT WAS MANUFACTURED AS DESIGNED. FAILURE ANALYSIS OF THE SCOPE COULD NOT BE PERFORMED AS THE SCOPE WAS DISCARDED. THE PHYSICIAN DOES NOT ATTRIBUTE THE DEATH TO THE GALAXY SYSTEM, INSTEAD STATING THAT IT WAS CAUSED BY BLEEDING FROM THE BIOPSY. THE PATIENT'S PRE-EXISTING CONDITION CONTRIBUTED TO AN INCREASED RISK. THIS CASE IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: A PATIENT'S DEATH OCCURRED FOLLOWING A GALAXY-ASSISTED BIOPSY PROCEDURE, AND STANDARD CODE PROTOCOLS WERE INITIATED. THE PHYSICIAN DOES NOT ATTRIBUTE THE DEATH TO THE GALAXY SYSTEM, INSTEAD STATING THAT IT WAS CAUSED BY BLEEDING FROM THE BIOPSY. ADDITIONALLY, THE PATIENT HAD A PRE-EXISTING CHEST TUBE FROM A HEALED PNEUMOTHORAX DUE TO A NECROTIC LESION IN THE LEFT LUNG PRIOR TO THE PROCEDURE AND WAS ALSO UNDERGOING CHEMOTHERAPY. NO MALFUNCTIONS WERE REPORTED. UPDATE B5: INITIAL INFORMATION WAS THE PATIENT WAS DESIGNATED AS A DO NOT RESUSCITATE (DNR). THIS IS INCORRECT, AS THE PATIENT WAS NOT DESIGNATED AS A DNR.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT'S DEATH OCCURRED FOLLOWING A GALAXY SYSTEM BIOPSY PROCEDURE FOR A LESION IN THE LEFT LOWER LOBE. THE PATIENT WAS INITIALLY REPORTED TO HAVE BLED IN ACCORDANCE WITH TYPICAL BIOPSY PROTOCOL, WITH BLEEDING APPEARING TO BE CONTROLLED PRIOR TO THE GALAXY SYSTEM BEING UNDOCKED. SUBSEQUENTLY, A HEMOTHORAX WAS DISCOVERED, FORMING A CONDUIT THROUGH NECROTIC TISSUE INTO THE PLEURAL SPACE. CODE PROTOCOL WAS INITIATED, AND CONSULTATIONS WERE CONDUCTED WITH AN INTERVENTIONAL RADIOLOGIST AND THORACIC SURGEON. IT IS IMPORTANT TO NOTE THAT THE PATIENT HAD A PRE-EXISTING CHEST TUBE FROM A HEALED PNEUMOTHORAX DUE TO A NECROTIC LESION IN THE LEFT LUNG PRIOR TO THE PROCEDURE AND WAS ALSO UNDERGOING CHEMOTHERAPY. NO MALFUNCTIONS WERE REPORTED AND THE SCOPE WAS DISCARDED. EFFORTS WERE MADE TO DETERMINE THE DEFINITIVE CAUSE OF DEATH; HOWEVER, THE PHYSICIAN DID NOT PROVIDE ADDITIONAL COMMENTS AND THE FAMILY HAS CHOSEN NOT TO PURSUE AN AUTOPSY REPORT. THE PATIENT WAS ALSO DESIGNATED AS DO NOT RESUSCITATE (DNR).

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT'S DEATH OCCURRED FOLLOWING A GALAXY SYSTEM BIOPSY PROCEDURE FOR A LESION IN THE LEFT LOWER LOBE. THE PATIENT WAS INITIALLY REPORTED TO HAVE BLED IN ACCORDANCE WITH TYPICAL BIOPSY PROTOCOL, WITH BLEEDING APPEARING TO BE CONTROLLED PRIOR TO THE GALAXY SYSTEM BEING UNDOCKED. SUBSEQUENTLY, A HEMOTHORAX WAS DISCOVERED, FORMING A CONDUIT THROUGH NECROTIC TISSUE INTO THE PLEURAL SPACE. CODE PROTOCOL WAS INITIATED, AND CONSULTATIONS WERE CONDUCTED WITH AN INTERVENTIONAL RADIOLOGIST AND THORACIC SURGEON. IT IS IMPORTANT TO NOTE THAT THE PATIENT HAD A PRE-EXISTING CHEST TUBE FROM A HEALED PNEUMOTHORAX DUE TO A NECROTIC LESION IN THE LEFT LUNG PRIOR TO THE PROCEDURE AND WAS ALSO UNDERGOING CHEMOTHERAPY. NO MALFUNCTIONS WERE REPORTED AND THE SCOPE WAS DISCARDED. EFFORTS WERE MADE TO DETERMINE THE DEFINITIVE CAUSE OF DEATH; HOWEVER, THE PHYSICIAN DID NOT PROVIDE ADDITIONAL COMMENTS AND THE FAMILY HAS CHOSEN NOT TO PURSUE AN AUTOPSY REPORT. THE PATIENT WAS NOT DESIGNATED AS DO NOT RESUSCITATE (DNR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059486 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 6025012112

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Death