MAUDE Adverse Event Report: Noah Medical Corp. Galaxy System; Galaxy System Bronchoscope

Catalog Number	GALB-001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a galaxy-assisted biopsy procedure targeting a 13 mm left upper lobe lesion located superior to the fissure.The procedure was completed successfully, and no galaxy system or bronchoscope malfunctions were observed or reported.A pneumothorax was identified on a post-procedure chest x-ray.A left chest tube was placed, and the patient was admitted.Attempts to gather additional patient demographics were unsuccessful.
Additional Manufacturer Narrative
Additional details from a noah clinical representative confirmed that the patient was asymptomatic at the time of diagnosis, the chest tube was the only intervention required, and the patient was admitted for two days before being discharged in good condition.The physician attributed the pneumothorax to biopsy sampling at the lesion site and did not attribute the event to the galaxy system.The patient reportedly had no relevant pre-existing medical conditions or pulmonary history.The bronchoscope was discarded following the procedure and was not available for investigation.System and bronchoscope manufacturing records were reviewed and found no issues associated with this case.Manufacturing records were reviewed and confirmed that the bronchoscope passed the final qa/qc check prior to release.Video and log review demonstrated successful system operation and three completed tilt+ imaging acquisitions with successful target updates.Seven unexpected scope shape alerts occurred, continued insertion following five alerts was identified as use error, and a bronchoscope shaft prolapse was observed.These findings are associated with procedure delay and do not reasonably suggest contribution to the pneumothorax.During subsequent navigation, the bronchoscope was, under physician control, advanced through the airway wall into parenchymal tissue, followed by continued biopsy sampling near the target with multiple passes.These observations support the physician's attribution that the pneumothorax was related to biopsy sampling at the lesion site rather than a galaxy system or bronchoscope malfunction.This mdr has been submitted because the patient experienced a pneumothorax requiring chest tube placement and hospital admission following a galaxy-assisted biopsy procedure.The physician attributed the pneumothorax to biopsy sampling at the lesion site.No galaxy system or bronchoscope malfunction related to the patient injury was reported or observed during the investigation.

• Brand Name: Galaxy System
• Common Device Name: Galaxy System Bronchoscope
• 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: michael chibbaro ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 50245249
• Report Number: 3021325287-2026-00040
• Device Sequence Number: 18671738
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)231128
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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: GALB-001
• Device Lot Number: 6026031101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2026
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Race: White