BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEM

    MDR report key: 24683802 · Received March 25, 2026

    Report

    Report Number
    3021325287-2026-00007
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 24, 2026
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION OBTAINED FROM NOAH REPRESENTATIVE INDICATED THAT THE PROCEDURE WAS PERFORMED WITHOUT NOAH CLINICAL SUPPORT. AN [ANOTHER MANUFACTURERS DEVICE] OLYMPUS TOWER WAS USED FOR INITIAL AIRWAY INSPECTION PRIOR TO GALAXY SYSTEM AND SCOPE INTRODUCTION, THE POSTERIOR MEMBRANE TEAR WAS NOT OBSERVED DURING THIS INITIAL EVALUATION NOR DURING GALAXY REGISTRATION. THE INJURY WAS FIRST IDENTIFIED DURING RE-NAVIGATION TO THE LESION AND WAS VISUALIZED AND MONITORED USING THE BRONCHOSCOPE THROUGHOUT THE PROCEDURE. THE SCOPE DID NOT APPEAR TO BE CENTERED WITHIN THE AIRWAY LUMEN, AND DIFFICULTY NAVIGATING TO THE LESION WAS REPORTED. DURING THE GALAXY PROCEDURE, ERRORS AND ALERTS WERE REPORTED, AND THE CAMERA (BRONCHOSCOPE) REQUIRED RESEATING. THE PHYSICIAN ATTRIBUTED THE INJURY TO THE BRONCHOSCOPE. THE SCOPE WAS DISCARDED FOLLOWING THE PROCEDURE. NO INTERVENTIONS WERE REPORTED, ALTHOUGH MINOR AIRWAY MANAGEMENT (E.G., SUCTIONING) COULD NOT BE DEFINITIVELY RULED OUT. THE SCOPE WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, MANUFACTURING RECORDS (LHR AND IQC) CONFIRMED THE DEVICE MET ALL SPECIFICATIONS FOR RELEASE. REVIEW OF PROCEDURE VIDEO, SYSTEM LOGS, AND DEVICE PERFORMANCE FOUND NO MECHANICAL OR NAVIGATION-RELATED MALFUNCTIONS, AND ALL SYSTEM ALERTS, WERE CONFIRMED TO HAVE TRIGGERED APPROPRIATELY AND FUNCTIONED AS INTENDED. VIDEO AND LOG ANALYSIS IDENTIFIED THE AIRWAY TEAR WAS ASSOCIATED WITH A SUDDEN RETRACTION OF A HEAVILY ARTICULATED BRONCHOSCOPE, FOLLOWING A PERIOD OF INCREASED TENSION CONSISTENT WITH THE SCOPE INTERACTING WITH AIRWAY ANATOMY. LOG DATA DEMONSTRATED A RELEASE OF BUILT-UP TENSION RESULTING IN A RAPID, MOVEMENT OF THE SCOPE, WITH THE INJURY VISUALIZED IMMEDIATELY AFTERWARD. MULTIPLE ALERTS WERE GENERATED PRIOR TO THE EVENT, AND WERE NOT CONSISTENTLY FOLLOWED BY CORRECTIVE ACTIONS SUCH AS FLUOROSCOPIC ASSESSMENT OR SCOPE RELAXATION BY THE USER. THE FINDINGS OF THE INVESTIGATION ARE MOST CONSISTENT WITH USE ERROR, SPECIFICALLY SIMULTANEOUS ARTICULATION AND RETRACTION OF THE BRONCHOSCOPE, INCLUDING PERIODS OF MAXIMUM ARTICULATION, WITHOUT RELAXING THE SCOPE DURING WITHDRAWAL AND WITHOUT APPROPRIATE RESPONSE TO REPEATED SYSTEM ALERTS AND TENSION INDICATIONS, CONTRARY TO IFU GUIDANCE. A SOFTWARE ANOMALY AFFECTING THE AUTO-STRAIGHTENING (HOOKING-PREVENTION) FEATURE WAS IDENTIFIED, IN WHICH STOPPING RETRACTION INTERRUPTED THE STRAIGHTENING SEQUENCE. THIS MALFUNCTION OCCURRED PRIOR TO THE ADVERSE EVENT AND BASED ON AVAILABLE LOG DATA, THERE IS NO EVIDENCE THAT THIS MALFUNCTION CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT; HOWEVER, A CAUSAL CONTRIBUTION CANNOT BE DEFINITIVELY RULED OUT. THIS MDR HAS BEEN SUBMITTED BECAUSE A MALFUNCTION OF THE GALAXY SYSTEM WAS IDENTIFIED INVOLVING THE AUTO-STRAIGHTENING (HOOKING-PREVENTION) FEATURE DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, WHICH HAS THE POTENTIAL TO CONTRIBUTE TO SERIOUS INJURY UNDER CERTAIN USE CONDITIONS, EVEN THOUGH A SERIOUS INJURY DID NOT OCCUR IN THIS CASE. THE PATIENT EXPERIENCED AN AIRWAY TEAR WITH ASSOCIATED BLEEDING; HOWEVER, NO INTERVENTION WAS REQUIRED AND THE PATIENT WAS DISCHARGED THE SAME DAY. INVESTIGATION DETERMINED THAT SYSTEM ALERTS FUNCTIONED AS INTENDED AND THE EVENT IS MOST CONSISTENT WITH USE ERROR INVOLVING SIMULTANEOUS ARTICULATION AND RETRACTION OF THE BRONCHOSCOPE. ALTHOUGH THERE IS NO EVIDENCE THAT THE IDENTIFIED MALFUNCTION CAUSED OR CONTRIBUTED TO THE EVENT, A CAUSAL CONTRIBUTION CANNOT BE DEFINITIVELY RULED OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A POSTERIOR MEMBRANE TEAR WITH ASSOCIATED BLEEDING DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE WHILE NAVIGATING TO A RIGHT UPPER LOBE (RUL) LESION. THE PROCEDURE WAS COMPLETED, NO INTERVENTIONS WERE REPORTED, THE PATIENT WAS OBSERVED POST OPERATIVELY AND DISCHARGED THE SAME DAY. THE PHYSICIAN ATTRIBUTED THE INJURY TO THE GALAXY BRONCHOSCOPE, AND CLAIMS IT OCCURRED WHILE NAVIGATING TO THE LESION. NO DEVICE MALFUNCTION WAS REPORTED AT THE TIME OF REPORTING. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469970 GALAXY SYSTEM GALAXY SYSTEM BRONCHOSCOPE EOQ NOAH MEDICAL CORP. GALB-001 2025100201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OLYMPUS TOWER