MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Catalog Number	CRB-1560
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a bronchoscopy procedure assisted by the noah galaxy system, the patient experienced a pneumothorax.A chest tube was inserted as an intervention.A device malfunction related to difficulty locating the lesion was reported during the procedure.However, this malfunction did not cause or contribute to the event.An initial investigation by an engineer determined that the lesion was not visible on the ct scan itself, which explains why it was difficult to visualize using tomo.Additionally, the physician does not attribute the pneumothorax to the use of the galaxy device.Upon review of the procedural log and video by a clinical engineer, it was observed that the biopsy tool was advanced too far, which may have contributed to the occurrence of the injury.This case is being reported to document the occurrence of pneumothorax during the procedure.
Event or Problem Description
During a galaxy-assisted bronchoscopy, the patient experienced a pneumothorax.In response, a chest tube was placed, and the patient was discharged the same day following its removal.The physician reported difficulty locating the lesion during the procedure, initially suspected to be a device malfunction.However, preliminary investigation by the engineer revealed that the lesion was not visible on the ct scan itself, which accounts for its absence on tomo.However, this issue did not cause or contribute to the pneumothorax.The physician does not attribute the injury to the use of the noah medical device.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM
• Manufacturer (Section D): NOAH MEDICAL CORP.; 2075 zanker road; san jose CA 95035
• 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: 22242395
• Report Number: 3021325287-2025-00025
• Device Sequence Number: 8176721
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: 010085004882504811241021
• 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): 06/15/2025

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
• Device Catalogue Number: CRB-1560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 78 KG