MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Model Number	GALB-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a galaxy-assisted biopsy of a lesion located at the right upper lobe, the patient developed pneumothorax.The injury was found on x-ray.The patient was treated with a chest tube and overnight admission.The physician states the injury is not a result of the galaxy system, and attributes the injury to the biopsy of lesion 1.No malfunctions were reported.Although there were no malfunctions reported, the use of the scope may have contributed to the injury.
Additional Manufacturer Narrative
Failure analysis was not performed as the scope was not returned.Video logs were reviewed and found no user errors were observed.The physician attributed the injury to the biopsy.No malfunctions were reported.The complaint is reported due to the following conclusion: during a galaxy-assisted biopsy procedure, the patient developed pneumothorax.The injury was found by x-ray.The patient was treated with a chest tube and admitted overnight.System manufacturing records were reviewed and found no issues associated with this case.Bronchoscope manufacturing records were reviewed and found no issues associated with this case.

• 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: 20799543
• Report Number: 3021325287-2024-00019
• Device Sequence Number: 6895289
• Product Code: EOQ
• UDI-Device Identifier: 00850048825000
• UDI-Public: 010085004882500010202408050117250200
• 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): 11/27/2024

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 Expiration Date: 02/01/2025
• Device Model Number: GALB-001
• Device Lot Number: 2024080501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White