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

Catalog Number	GALB-001
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a galaxy-assisted biopsy of a right lower lobe lesion.During the procedure, anesthesia identified a several-hundred-cubic-centimeter air leak that affected ventilation.The breathing circuit was checked and confirmed closed, and the leak was localized to the interface between the bronchoscope and bronch connector.Saline-soaked gauze partially reduced the leak, and vaseline gauze subsequently resolved it completely.The patient remained stable, and the procedure was completed without recurrence of the leak.At the end of the procedure, after the bronchoscope was retracted to the endotracheal tube, a right pneumothorax was identified during post-procedure fluoroscopy.A chest tube was placed, and the patient was admitted for management.Attempts to gather additional patient demographics were unsuccessful.
Additional Manufacturer Narrative
Additional information from a noah clinical representative stated that, as of ten days after the procedure, the patient remained hospitalized.The physician stated before the procedure that the patient was at increased risk for pneumothorax due to the patient's interstitial lung disease and the location of the lesion near the pleura and diaphragm.The bronch connector was returned for investigation, and the bronchoscope was discarded after the procedure.System and bronchoscope manufacturing records were reviewed and found no issues associated with this case.Manufacturing records confirmed that the bronchoscope and bronch connector passed the applicable final qa/qc inspections prior to release.Video review demonstrated successful galaxy system operation and biopsy activity near the pleura and diaphragm, with no system performance issue related to the pneumothorax observed.Hardware evaluation confirmed that the bronch connector could leak at the seal cap-to-scope interface when used with a smaller-diameter scope shaft, consistent with the reported leak resolving after vaseline gauze application.The physician considered the patient at increased risk for pneumothorax due to the underlying interstitial lung disease and peripheral lesion location.The available information does not indicate that the pneumothorax was attributed to the galaxy system or bronch connector leak.This mdr has been submitted because the patient experienced a right pneumothorax requiring chest tube placement and hospitalization following a galaxy-assisted bronchoscopy procedure.The investigation confirmed a bronch connector sealing issue that caused temporary ventilation difficulty, however, the leak was resolved during the procedure, the patient remained stable, and the investigation does not reasonably suggest that the connector leak caused or contributed to the pneumothorax.No galaxy system or bronchoscope malfunction related to the patient injury was reported or observed.

• 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: 50172456
• Report Number: 3021325287-2026-00039
• Device Sequence Number: 20921325
• Product Code: EOQ
• UDI-Device Identifier: 00850048825086
• UDI-Public: (01)00850048825086(11)251023
• 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): 08/07/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GALB-001
• Device Lot Number: 6026032501
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 152 LB
• Patient Race: White