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	09/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System manufacturing records were reviewed, and no issues were identified.Bronchoscope manufacturing record review could not be completed, as the scope shaft is unreadable and logs were unavailable.Failure analysis found that the scope, video, and em systems functioned as intended, with no confirmed device malfunction.Scope buckling was linked to user input, and the tool's absence prevented further evaluation.The video loss was likely due to a transient mechanical disturbance, and em signal loss was brief and self-resolved.None of these issues were determined to have caused the pneumothorax.Video review could not be performed due to log unavailability.The physician did not attribute the event to the galaxy system, citing the patient's emphysema and lesion location as contributing factors, and the injury was managed conservatively.This complaint is reported due to the following conclusions: a pneumothorax was reported after a galaxy-assisted biopsy procedure and a chest tube was inserted.The physician did not attribute the pneumothorax to the galaxy system, stating that it was related to the patient's pre-existing emphysema and the challenging location of the lesion.Reported malfunctions included scope buckling, loss of video, and em signal loss.
Event or Problem Description
A pneumothorax was identified post-galaxy procedure, and a chest tube was inserted.The patient had a valve placed previously due to severe emphysema, and the physician noted that it was the anesthesiologist who opted to insert the chest tube.Reported malfunctions included scope buckling, loss of video, and em signal loss.

• 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: 23498907
• Report Number: 3021325287-2025-00039
• Device Sequence Number: 18390512
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)230516
• 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): 11/07/2025

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: 09/08/2023
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• 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
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American