MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	09/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System manufacturing records were reviewed, and no issues were identified.Bronchoscope manufacturing record review could not be completed, as the scope was discarded and logs were unavailable.The scope was not returned, and failure analysis or video review could not be performed due to unavailable logs and device data.The physician confirmed the seizures were unrelated to the galaxy procedure, attributing them to the patient's recent head trauma and pre-existing condition.The event was determined to be patient-related and not associated with device performance or procedural factors.This complaint is reported due to the following conclusions: multiple seizures were reported after a galaxy-assisted biopsy procedure, occurring after the patient awoke from anesthesia.The patient was admitted to the icu for monitoring and subsequently recovered without complications.The physician did not attribute the injury to the galaxy system, stating it was related to the patient's recent head trauma.No device malfunctions were reported.
Event or Problem Description
The patient experienced multiple post-operative seizures after awakening from anesthesia following a galaxy-assisted bronchoscopy procedure.The patient was admitted to the icu and recovered without complications.No device malfunctions were reported.

• 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: 23498995
• Report Number: 3021325287-2025-00040
• Device Sequence Number: 8858303
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)230516
• 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): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Race: White