MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Catalog Number	CRB-1537
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a noah galaxy-assisted bronchoscopy procedure, the patient experienced a pneumothorax, which required chest tube placement as an intervention.A device malfunction occurred during the procedure, where the user was initially unable to obtain a radial view during breath holds.The issue was resolved after performing a re-tilt, and therefore is unlikely to have caused or contributed to the pneumothorax.Log review by a clinical engineer indicated that the lesion was located between the diaphragm and fissure with an increased risk of pneumothorax.Additionally, it was noted that the tool was inserted too far during the procedure, suggesting a potential use error.The physician does not attribute the pneumothorax to the galaxy system, but rather to the biopsy procedure itself.
Event or Problem Description
During a galaxy-assisted bronchoscopy procedure, the patient experienced a pneumothorax, which was managed by the placement of a chest tube.A device malfunction occurred during the procedure, where the user was initially unable to obtain a radial view during breath holds.The issue was resolved after performing a re-tilt, and therefore is unlikely to have caused or contributed to the pneumothorax.The physician did not attribute the injury to the use of the galaxy system, but rather to the biopsy procedure itself.Attempts to collect patient demographics were unsuccessful.

• 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: 22647079
• Report Number: 3021325287-2025-00026
• Device Sequence Number: 8678227
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: 010085004882504811240220
• 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): 07/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CRB-1537
• 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: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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
• Patient Sex: Unknown