BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALAXY SYSTEM

    MDR report key: 24533731 · Received March 6, 2026

    Report

    Report Number
    3021325287-2026-00004
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 6, 2026
    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

    ADDITIONAL INFORMATION INDICATED THAT BLEEDING BEGAN AFTER THE FINAL BIOPSY, AND THE PHYSICIAN INITIALLY ATTEMPTED TAMPONADE USING THE BRONCHOSCOPE. HOWEVER, THE SCOPE WAS NOT IN A TIGHT WEDGE POSITION, ALLOWING BLOOD TO LEAK AROUND THE SCOPE AND BECOME VISIBLE IN THE ETT APPROXIMATELY 30 SECONDS LATER. THE SCOPE WAS THEN REMOVED, AND A THERAPEUTIC BRONCHOSCOPE WAS INTRODUCED TO ACHIEVE TAMPONADE OVER APPROXIMATELY 25-30 MINUTES. THE PATIENT WAS ADMITTED AND DISCHARGED IN STABLE CONDITION AFTER TWO DAYS. THE SCOPE WAS RETURNED FOR INVESTIGATION, AND INSPECTION AND FUNCTIONAL TESTING CONFIRMED NO DEFECTS, WITH MANUFACTURING RECORDS VERIFYING THE DEVICE MET ALL FINAL QA/QC RELEASE CRITERIA. NO HARDWARE-RELATED ISSUES WERE IDENTIFIED. VIDEO REVIEW IDENTIFIED NO GALAXY SYSTEM MALFUNCTIONS OR USE ERRORS. ALL BIOPSY ACTIVITY REMAINED WITHIN THE AF BOUNDARY, AND BLEEDING WAS FIRST OBSERVED FOLLOWING BIOPSY ATTEMPTS, PROGRESSING WITH CONTINUED SAMPLING. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE GALAXY SYSTEM AND STATED IT WAS CAUSED BY BIOPSY OF A LESION ADJACENT TO THE PULMONARY ARTERY. VIDEO REVIEW SUPPORTS THIS, DEMONSTRATING EXPECTED SYSTEM PERFORMANCE, APPROPRIATE TOOL POSITIONING, AND NO DEVICE-RELATED CONTRIBUTION TO THE EVENT. THIS MDR HAS BEEN SUBMITTED BECAUSE THE PATIENT EXPERIENCED BRONCHIAL BLEEDING REQUIRING HEMOSTATIC INTERVENTION AND HOSPITALIZATION DURING A GALAXY-ASSISTED BIOPSY PROCEDURE. NO MALFUNCTIONS OF THE GALAXY SYSTEM OR SCOPE RELATED TO THE PATIENT INJURY WERE REPORTED OR OBSERVED DURING THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 75-YEAR-OLD, FEMALE, UNDERWENT A GALAXY-ASSISTED BIOPSY PROCEDURE FOR A LESION IN THE LEFT LOWER LOBE. THERE WAS NO ALLEGATION OF GALAXY SYSTEM MALFUNCTION. DURING THE PROCEDURE, BRONCHIAL BLEEDING WAS NOTED AFTER THE FINAL FORCEPS BIOPSY AS THE CASE WAS CONCLUDING. BLOOD WAS VISUALIZED IN THE ENDOTRACHEAL TUBE (ETT), PROMPTING WITHDRAWAL OF THE BRONCHOSCOPE AND REPOSITIONING OF THE ROBOTIC SYSTEM TO MANAGE THE PATIENT. A BALLOON WAS USED FOR TAMPONADE AND TOPICAL TRANEXAMIC ACID (TXA) WAS ADMINISTERED UNTIL HEMOSTASIS WAS ACHIEVED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY. THE PHYSICIAN DID NOT ATTRIBUTE THE BLEEDING TO THE GALAXY SYSTEM AND STATED THE LESION WAS LOCATED ADJACENT TO THE PULMONARY ARTERY, WITH BLEEDING CAUSED BY BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350091 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE EOQ NOAH MEDICAL CORP. GALB-001 2025090902

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention| H