MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Catalog Number	CRB-1565
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A small a small pneumothorax occurred in a patient during a galaxy-assisted bronchoscopy procedure.No intervention was required to treat the pneumothorax.A malfunction related to flickering augmented fluoro was reported during the case.However, the physician confirmed that this issue did not cause or contribute to the injury.Instead, the pneumothorax resulted from the crna removing the patient from breath hold at the moment the needle was deployed.The physician does not attribute the injury to the galaxy device but rather to the breath hold change.A clinical engineer conducted an investigation, including a review of the video recording log.The findings confirmed no malfunctions or use errors associated with the galaxy device.This case is reported to document the occurrence of pneumothorax during the procedure.
Event or Problem Description
During a galaxy-assisted bronchoscopy procedure, the patient experienced a small pneumothorax.No intervention was required as a result of the pneumothorax.During the case, flickering augmented fluoro was observed as a malfunction.However, this issue did not cause or contribute to the injury.The pneumothorax occurred due to the crna removing the patient from breath hold at the moment the needle was deployed.The physician does not attribute the pneumothorax to the noah medical device but rather to the breath hold change.

• 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 ; 3412266514
• MDR Report Key: 21537709
• Report Number: 3021325287-2025-00011
• Device Sequence Number: 20797773
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)241209
• 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): 02/28/2025

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-1565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2024
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White