MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM; GALAXY SYSTEM BRONCHOSCOPE

Catalog Number	GAL-001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a male patient of unknown age underwent a galaxy-assisted biopsy procedure for a pleural-adjacent anterior lesion in the right lung (lesion information identified during investigation and not provided in the initial complaint).An allegation of inability to visualize the lesion using the galaxy system was reported.It was reported that a pneumothorax occurred toward the end of the procedure, which required placement of a chest tube.No additional interventions were reported.Hospital staff indicated that they were unable to locate the lesion despite multiple troubleshooting attempts.Attempts to gather additional patient demographics were unsuccessful.
Additional Manufacturer Narrative
Additional information confirmed that the patient did not require hospital admission.The physician attributed the injury to inability to visualize the lesion, stating this led to advancement through lung tissue.The bronchoscope was discarded and therefore not returned for evaluation.A rebus device was used concomitantly.As the bronchoscope was not returned, manufacturing record review could not be performed, and device evaluation was limited to available procedural data, including video and system logs.System manufacturing records were reviewed and found no issues associated with this event.A thorough investigation, including video and log review, confirmed that the galaxy system functioned as intended, with no device malfunctions, software errors, or navigation inaccuracies identified.Input fluoro images were good quality, pointing to correct c-arm setting selection and use.The target lesion was clearly visible in the procedural reconstruction.Imaging data confirmed appropriate lesion localization and no anomalies were identified in the system's reconstructed output.Video review showed repeated instances where the lesion was not selected, resulting in prolonged targeting.During the procedure, a parenchymal break with bleeding occurred following tool advancement through lung tissue, and biopsy activity was largely performed within the af boundary.An operator-related use error involving scope articulation with a deployed [another manufacturers] tool contributed to minor bleeding.The physician's attribution of inability to visualize the lesion is not supported by video review, as lesion visualization and targeting were achieved during the procedure.This mdr has been submitted because the patient experienced a pneumothorax requiring chest tube placement during a galaxy-assisted biopsy procedure.An allegation of malfunction related to inability to visualize the lesion was reported; however, investigation determined that the galaxy system functioned as intended, and no device malfunction was identified that contributed to the patient injury.

• 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: jd wilson ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 24670557
• Report Number: 3021325287-2026-00006
• Device Sequence Number: 12041666
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)240826
• 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): 03/23/2026

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: GAL-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RADIAL PROBE ENDOBRONCHIAL ULTRASOUND (REBUS)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male