BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEN

    MDR report key: 24916745 · Received April 17, 2026

    Report

    Report Number
    3021325287-2026-00013
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 23, 2026
    Report Date
    April 17, 2026
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    PMA / PMN Number
    K223144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR HAS BEEN SUBMITTED BECAUSE RETRACTION, NOT EXPECTED BY THE USER, OCCURRED DURING A GALAXY-ASSISTED BIOPSY PROCEDURE. THE INVESTIGATION REVIEWED MANUFACTURING RECORDS, THE RETURNED BRONCHOSCOPE, AND SYSTEM LOG FILES FROM THE CASE. ANALYSIS DETERMINED THE OBSERVED RETRACTION WAS CAUSED BY A REGISTERED DISCONNECTION SIGNAL AT THE SCOPE MOUNTING INTERFACE. NO PATIENT HARM WAS REPORTED. THIS MDR WAS SUBMITTED PROACTIVELY BECAUSE RECURRENCE OF THIS MALFUNCTION COULD POTENTIALLY RESULT IN SERIOUS INJURY. INVESTIGATION FOUND THERE IS A DISCREPANCY BETWEEN THE USER-REPORTED EVENT AND SYSTEM BEHAVIOR. FOLLOWING A PARTIAL ARM RETRACTION AND SCOPE ATTACHED DURING RETRACTION (SADR) ALERT, RECOVERY ACTIONS WERE INITIATED; HOWEVER, THE SCOPE WAS NOT REMOVED FOR A SUFFICIENT DURATION TO ALLOW THE AUTO-RETRACTION SEQUENCE TO COMPLETE. SUBSEQUENTLY, THE USER PERFORMED THE CORRECT RECOVERY STEPS. DURING A SUBSEQUENT AUTO-RETRACTION ATTEMPT, A HIGH ARM VELOCITY ALERT WAS TRIGGERED. THIS IS A KNOWN SOFTWARE BEHAVIOR THAT MAY OCCUR DURING AUTO-RETRACTION INITIATION. NO COLLISION DETECTED ERROR WAS OBSERVED. THE ALERT RECOVERY STEPS ARE NOT CONSIDERED CONTRIBUTORY TO THE UNEXPECTED RETRACTION EVENT.

    Description of Event or Problem · 0

    DURING A GALAXY SYSTEM-ASSISTED PROCEDURE, THE USER REPORTED ISSUES INCLUDING LOSS OF CAMERA VISUALIZATION, ARM RETRACTION, AND SYSTEM ERROR MESSAGES RELATED TO SCOPE ATTACHMENT. APPROXIMATELY HALFWAY THROUGH THE BIOPSY, THE BRONCHOSCOPE LOST CAMERA VISUALIZATION. APPROXIMATELY 3-5 SECONDS LATER, THE ROBOTIC ARM INITIATED A SLIGHT RETRACTION, CONSISTENT WITH BEHAVIOR OBSERVED DURING A SCOPE DISCONNECTION EVENT; THIS MOTION STOPPED SPONTANEOUSLY. SUBSEQUENTLY, SYSTEM ERROR MESSAGES WERE DISPLAYED, INCLUDING "SCOPE ATTACHED DURING E-STOP" AND "SCOPE ATTACHED DURING RETRACTION." THE USER REMOVED THE SCOPE AND ATTEMPTED RECOVERY; HOWEVER, THE ARM DID NOT RETRACT AT THAT TIME. AFTER THE ERROR MESSAGES CLEARED AND THE USER INTERFACE RETURNED, THE SYSTEM ENTERED ANOTHER E-STOP CONDITION AND DISPLAYED "HIGH INSERTION FORCE DETECTED," DESPITE NO USER INTERACTION WITH THE ARM OR CONTROLLER AND NO OBSERVED ARM MOVEMENT. FOLLOWING A SECOND SCOPE REMOVAL, THE SYSTEM SUCCESSFULLY COMPLETED A RECOVERY SEQUENCE, AND FULL ARM RETRACTION OCCURRED AS EXPECTED. THE SCOPE WAS REINSERTED, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED. ATTEMPTS TO GATHER ADDITIONAL PATIENT DEMOGRAPHICS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977358 GALAXY SYSTEN GALAXY SYSTEM EOQ NOAH MEDICAL CORP. GALB-001 6025110403

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown