MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Medical Device Problem Codes	Break (1069); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
System, scope and wired controller manufacturing records were reviewed and found no issues associated with this case.Failure analysis performed shows that the failure mode is likely to push the potentiometer into a non-zero position at rest and is therefore likely to cause unintended motion.Although this is not what occurred during the case.Review of the logs indicate that when the joystick broke, the reading was below the dead zone and thus no command to move was issued.When the wired controller was shipped back to noah medical, the joystick position was shifted, resulting in a higher reading than when the failure occurred.No other malfunctions were reported.The complaint is reported due to the following conclusions: during a galaxy-assisted biopsy procedure, the left thumb joystick of controller (b)(6) broke leading to a replacement.There were no injuries reported or treatment administered.This complaint is reported due to the 2-year reportability rule.
Event or Problem Description
It was reported that during a galaxy-assisted biopsy of a lesion located in the right upper lobe, the controller (b)(6) left thumb joystick broke.The user replaced the controller.There were no injuries reported or treatment administered.No other malfunctions were reported.Although there were no injuries reported, the investigation findings indicated the potential for unintended motion.

• 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: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 21608669
• Report Number: 3021325287-2025-00004
• Device Sequence Number: 9275458
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)240402
• 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): 03/14/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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