BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEM

    MDR report key: 23154483 · Received September 26, 2025

    Report

    Report Number
    3021325287-2025-00019
    Event Type
    Malfunction
    Date Received
    September 26, 2025
    Date of Event
    August 21, 2024
    Report Date
    September 26, 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. FAILURE ANALYSIS WAS NOT PERFORMED AS THE SCOPE WAS NOT RETURNED. RECORDS CONFIRM THAT IT PASSED ALL FINAL QA/QC TESTING. VIDEO REVIEW SHOWED NO MALFUNCTIONS OR USE ERRORS. AT 11:29, THE PHYSICIAN MAY HAVE ARTICULATED INTO THE PARENCHYMA; AT 12:10, IRRIGATION WAS APPLIED TO WHAT APPEARED TO BE AN AIRWAY TEAR BEFORE RETRACTING. THE PROCEDURE CONTINUED WITH MULTIPLE BIOPSIES, WITH MINOR BLEEDING INTERMITTENTLY MANAGED BY SALINE, AND ENDED WITH SCOPE RETRACTION TO CHECK FOR RESIDUAL BLEEDING. ALTHOUGH THE PHYSICIAN SUGGESTED THE SCOPE TIP DESIGN CAUSED THE AIRWAY TEAR, THE BLEEDING WAS EFFECTIVELY MANAGED WITH IRRIGATION ALONE, AND NO FURTHER INTERVENTION WAS NEEDED. WITH THE SCOPE DISCARDED, PHYSICAL INSPECTION WAS NOT POSSIBLE, BUT QA/QC CONFIRMED THE DEVICE MET SPECIFICATIONS. THE INJURY IS MORE CONSISTENT WITH THE KNOWN INHERENT RISKS OF BRONCHOSCOPY. THE COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSIONS: DURING A GALAXY-ASSISTED BIOPSY PROCEDURE, THE PATIENT SUSTAINED AN AIRWAY TEAR AND EXPERIENCED BLEEDING. THE BLEEDING WAS CONTROLLED WITH IRRIGATION, AND NO FURTHER INTERVENTION WAS REQUIRED. THE PHYSICIAN ATTRIBUTES THE INJURY TO THE SCOPE TIP.

    Description of Event or Problem · 0

    AN AIRWAY (BRONCHIAL) TEAR AND BLEEDING WAS REPORTED WHILE THE PATIENT WAS UNDERGOING A GALAXY-ASSISTED BIOPSY PROCEDURE. THE INJURY OCCURRED DURING GUIDED NAVIGATION THROUGH A PERIPHERAL AIRWAY. THE USER WAS NAVIGATING NORMALLY, AND A TEAR WAS OBSERVED PRIOR TO SAMPLING. AFTERWARDS, BLEEDING WAS OBSERVED FOLLOWING SAMPLING, WHICH WAS MANAGED WITH SALINE. THERE WERE NO FURTHER INTERVENTIONS, COMPLICATIONS, OR MALFUNCTIONS REPORTED. ATTEMPTS TO COLLECT PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282271 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 2024070302

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female