MAUDE Adverse Event Report: NOAH MEDICAL CORP GALAXY SYSTEM; GALAXY SYSTEM, PRODUCT GAL-001

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The scope was not returned for investigation.The specific scope used in this case could not be confirmed, and a complete device-specific record review could not be performed.Video review identified no use errors and confirmed that the lesion was located close to the pleura.Parenchyma-like tissue briefly appeared in the camera view, which may indicate parenchymal breakthrough as the physician intentionally advanced to access the lesion.The physician proceeded with the procedure and subsequent biopsies, with no deviations from expected workflow noted.The physician did not attribute the pneumothorax to the galaxy system and stated that the injury was due to the nature and anatomy of the lesion.Given the lesion's pleural location, cystic characteristics, and the timing of symptom development, the event is consistent with the known inherent risks associated with bronchoscopy and transbronchial biopsy.
Event or Problem Description
The patient underwent a galaxy-assisted bronchoscopy procedure and was discharged home the same day without complications.Three days later, the patient reported worsening chest pain and was instructed to present to the emergency department, where a small right-sided pneumothorax was identified.A chest tube was placed and remained in place for 48 hours.The patient was discharged home after 72 hours and reported to be in good condition.No malfunctions were reported.Attempts to gather additional patient demographics were unsuccessful.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM, PRODUCT GAL-001
• Manufacturer (Section D): NOAH MEDICAL CORP; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 23762316
• Report Number: 3021325-2025-00066
• Device Sequence Number: 18664867
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)230905
• 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): 12/08/2025

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): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2023
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White