BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY SYSTEM

    MDR report key: 24749552 · Received March 31, 2026

    Report

    Report Number
    3021325287-2026-00009
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 31, 2026
    Manufacturer
    NOAH MEDICAL CORP.
    Product Code
    EOQ
    UDI-DI
    00850048825048
    PMA / PMN Number
    K223144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SYSTEM AND WIRED CONTROLLER MANUFACTURING RECORDS WERE REVIEWED AND FOUND NO ISSUES ASSOCIATED THIS MDR HAS BEEN SUBMITTED BECAUSE A NON-COMMANDED RETRACTION OCCURRED DURING A GALAXY-ASSISTED BIOPSY PROCEDURE. NO PATIENT HARM WAS REPORTED. A MALFUNCTION INVOLVING UNINTENDED ARM RETRACTION WITHOUT CONTROLLER INPUT WAS IDENTIFIED. INVESTIGATION OF SYSTEM LOGS DETERMINED THAT THE WIRED CONTROLLER (B)(6) EXHIBITED JOYSTICK DRIFT, RESULTING IN UNINTENDED MOVEMENT OF THE END EFFECTOR (IDM). THE MOST LIKELY ROOT CAUSE IS THE JOYSTICK'S NEUTRAL POSITION RESTING OUTSIDE THE DEADZONE, GENERATING AN OUTPUT SIGNAL. ALTHOUGH NO INJURY OCCURRED IN THIS CASE, RECURRENCE OF THIS MALFUNCTION COULD POTENTIALLY RESULT IN SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A GALAXY-ASSISTED BRONCHOSCOPY PROCEDURE, THE USER EXPERIENCED NON-COMMANDED RETRACTION OF THE BRONCHOSCOPE AFTER THE CONTROLLER WAS SET DOWN. WHILE THE PHYSICIAN STEPPED AWAY TO RETRIEVE A RADIAL PROBE, THE ARM CONNECTED TO THE SCOPE WAS OBSERVED TO BE ACTIVELY RETRACTING. AFTER RE-NAVIGATION TO THE LESION, A SECOND UNCOMMANDED RETRACTION OCCURRED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION FROM A NOAH REPRESENTATIVE CONFIRMED THAT THERE WERE NO SYSTEM ERRORS OR ALERTS ASSOCIATED WITH THE RETRACTION EVENTS. AT THE TIME, THE CONTROLLER WAS NOT IN USE AND WAS RESTING ON THE SYSTEM. THE SCOPE WAS OBSERVED TO MOVE FROM APPROXIMATELY 20 MM TO 48 MM FROM THE TARGET DURING THE EVENT. THE CONTROLLER WAS REPORTEDLY PLACED WITH THE BUTTONS FACING UPWARD, AND NO OBVIOUS STUCK BUTTONS OR OFF-NEUTRAL JOYSTICK POSITION WERE OBSERVED. PATIENT DEMOGRAPHICS WERE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811453 GALAXY SYSTEM GALAXY SYSTEM EOQ NOAH MEDICAL CORP. 00850048825048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown