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	07/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information provided by the noah clinical representative confirmed that chest tube placement and hospital admission were the only interventions required.The patient was discharged three days after the procedure in good condition.The physician attributed the pneumothorax to the biopsy based on the location of the nodule, which was described as pleural-based and extremely anterior.Needle and forceps biopsy tools were used during the procedure; the brands were not provided.No galaxy system malfunctions were observed.The bronchoscope was discarded and was not available for return and investigation.System and bronchoscope manufacturing records were reviewed and found no issues associated with this case.Manufacturing records confirmed the bronchoscope passed final qa/qc inspection.Video and log review demonstrated successful system workflows and four tilt+ imaging acquisitions.Early scope-related alerts and a later controller dropped alert were recovered, with no evidence that these events contributed to the pneumothorax.Biopsy activity included probe, needle, and forceps sampling at a peripheral target, with apparent airway wall penetration and post-biopsy bleeding were observed.These findings, together with the pleural-based and extremely anterior lesion location, support the physician's attribution of the pneumothorax to biopsy-related tissue interaction.No galaxy system malfunction associated with the injury was reported or observed.This mdr has been submitted because the patient experienced a pneumothorax requiring chest tube placement and hospitalization following a galaxy-assisted biopsy procedure.No malfunctions of the galaxy system or bronchoscope related to the patient injury were reported or observed during the investigation.
Event or Problem Description
Seven days after the biopsy procedure, noah medical was made aware that a patient experienced a pneumothorax following a galaxy-assisted biopsy procedure.The procedure involved biopsy of a right upper lobe (rul) lesion and was completed successfully.The pneumothorax was identified on a post-procedure x-ray.A chest tube was placed, and the patient was admitted to the hospital.Attempts to gather additional patient demographics were unsuccessful.

• 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: 50286839
• Report Number: 3021325287-2026-00041
• Device Sequence Number: 13185429
• Product Code: EOQ
• UDI-Device Identifier: 00850048825086
• UDI-Public: (01)00850048825086(11)251114
• 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): 08/17/2026

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: 6026020405
• 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: 07/20/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2026
• 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: 78 YR
• Patient Sex: Female
• Patient Race: White