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

Catalog 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	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 41-year-old male patient underwent a galaxy-assisted bronchoscopy procedure for a lesion in the left lower lobe.There was no allegation that a malfunction of the galaxy system occurred.The procedure was completed, and a pneumothorax was identified following the procedure.A chest tube was placed.Attempts to gather additional patient demographics were unsuccessful.
Additional Manufacturer Narrative
Additional information from the noah clinical representative stated that the pneumothorax was identified after the 4th tilt+ imaging acquisition, and the physician confirmed suspicion of the pneumothorax through continuous fluoroscopy shots.The target lesion was a 7 mm lesion in the lll and was described as difficult to access and located in a high-risk location near a fissure.Sampling was primarily obtained for infectious disease evaluation.The physician did not attribute the pneumothorax to the galaxy system and stated the event was due to the lesion location and biopsy tool puncture.No galaxy system malfunctions, errors, or abnormal system behavior were reported or observed during the procedure.The pneumothorax was treated with chest tube placement.No additional intervention besides the chest tube was reported.The patient was transferred from another hospital in poor condition and was admitted after the procedure; however, no additional information was provided regarding admission duration, complications during admission, or discharge condition.Pre-existing conditions were not provided.Reported concomitant devices included a biopsy needle, brand names were not recalled.The bronchoscope was discarded and was not available for return or failure analysis.Manufacturing records were reviewed and confirmed the bronchoscope passed final qa/qc check prior to release.Video review demonstrated that the galaxy system functioned as intended.The lesion was a difficult 7 mm lll lesion located near the periphery and in a high-risk location near a fissure.Biopsy activity was performed using tools consistent with a needle and forceps.The user reached approximately 11-13 mm from target center and performed biopsy passes within the af circle.During later biopsy activity, approximately six forceps passes were performed, and one forceps pass appeared inferior to the lesion near the periphery before the tool was quickly retracted and no further biopsies were performed.The bronchoscope was then retracted, and the chest cavity was assessed using live fluoroscopy.A cart brakes disengaged alert was observed near the conclusion of the procedure.No galaxy system malfunctions, errors, or abnormal system behavior related to the reported pneumothorax were observed.The physician's attribution to lesion location and biopsy tool puncture is supported by the available complaint information and video review, and the event is most consistent with procedural and anatomical factors rather than a galaxy system malfunction.This mdr has been submitted because the patient experienced a pneumothorax requiring chest tube placement and hospital admission following a galaxy-assisted bronchoscopy procedure.No malfunctions, errors, or abnormal system behavior of the galaxy system or bronchoscope related to the patient injury were reported or observed during the investigation.The physician attributed the event to the high-risk lesion location and biopsy tool puncture.

• 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: 50108842
• Report Number: 3021325287-2026-00038
• Device Sequence Number: 13452185
• Product Code: EOQ
• UDI-Device Identifier: 00850048825000
• UDI-Public: (01)00850048825000(10)6026040201
• 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): 08/01/2026

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: 6026040201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2026
• 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: 41 YR
• Patient Sex: Male
• Patient Race: Black Or African American