MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/21/2024
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 logs were unavailable, preventing failure analysis or video review.The reported camera frame-rate alert reflected expected software behavior and did not contribute to the event.The physician did not attribute the pneumothorax to the galaxy system, citing the lesion's location near the fissure/pleura and the patient's history of smoking and prior necrotizing granuloma, indicating increased procedural risk.The event is consistent with known inherent risks of bronchoscopy.This complaint is reported due to the following conclusions: a pneumothorax was identified on post-procedure chest x-ray following a galaxy-assisted biopsy.A chest tube was inserted, and the patient was admitted overnight.The physician did not attribute the injury to the galaxy system, determining it was related to the lesion's location near the fissure/pleura.A camera frame-rate error was reported.
Event or Problem Description
The pneumothorax was identified post-procedure on chest x-ray.The lesion was noted to be in close proximity to the fissure/pleura.A chest tube was inserted and the patient admitted overnight.A camera frame rate error was 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: 23513493
• Report Number: 3021325287-2025-00046
• Device Sequence Number: 9770268
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)231128
• 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: 02/21/2024
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• 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: 61 YR
• Patient Sex: Unknown
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander