MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM
• Manufacturer (Section D): NOAH MEDICAL CORP.; 2075 zanker road; san jose CA 95131
• Manufacturer (Section G): NOAH MEDICAL CORP.; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: jd wilson ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 24749552
• Report Number: 3021325287-2026-00009
• Device Sequence Number: 8672870
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)240711
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K223144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown