MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Catalog Number	CRB-1514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2024, following a galaxy-assisted bronchoscopy procedure, the patient was transferred to the pacu, where the physician identified a pneumothorax.As a result, the patient was hospitalized and monitored by the medical staff.No chest tube intervention was required.No malfunctions of the noah galaxy device were reported during the procedure.The physician does not attribute the injury to the device but rather to a complication of the biopsy procedure.Notably, the patient also had a history of pneumothorax.A clinical engineer reviewed the procedure video log, and the investigation found no malfunctions or user errors associated with the galaxy device.This case is being reported retrospectively to document the pneumothorax.
Event or Problem Description
On (b)(6) 2024, following a galaxy-assisted procedure, the patient was transferred to the pacu, where the physician identified a pneumothorax.As a result, the patient was hospitalized for observation; however, no chest tube intervention was required.The physician does not attribute the injury to the use of the noah galaxy device but instead considers it a complication of the biopsy procedure.No malfunctions or irregularities were reported with the galaxy device, which functioned as expected throughout the procedure.

• 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: 21370348
• Report Number: 3021325287-2025-00005
• Device Sequence Number: 8519199
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: 010085004882504811230906
• 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): 02/12/2025

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-1514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic
• Patient Race: White