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	Pneumothorax (2012)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System and bronchoscope manufacturing records were reviewed and found no issues associated with this case.The specific scope used could not be identified due to missing patient information and unavailable logs; therefore, manufacturing and video reviews could not be performed.The physician did not attribute the pneumothorax to the galaxy system and did not specify a cause.Based on available information, the pneumothorax is consistent with the known inherent risks of bronchoscopy and biopsy procedures.This complaint is reported due to the following conclusions: a pneumothorax was reported following a galaxy-assisted biopsy procedure.A pigtail catheter was inserted, and the patient was admitted for eight days.No malfunctions were reported.
Event or Problem Description
The pneumothorax was identified post-procedure, and a pigtail catheter was inserted.The patient was admitted for approximately one week and later recovered.No 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: 23650084
• Report Number: 3021325287-2025-00057
• Device Sequence Number: 18655754
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)231103
• 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): 11/25/2025

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: 04/25/2024
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2023
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White