MAUDE Adverse Event Report: NOAH MEDICAL CORP GALAXY SYSTEM; GALAXY SYSTEM BRONCHOSCOPE GALB-001

Model Number	GAL-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Upper Respiratory Tract Injury (4599)
Date of Event	10/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
System manufacturing records were reviewed and found no issues associated with this case.Due to unavailable system logs, the specific scope used in this case could not be confirmed, and a complete device-specific record review could not be performed.The scope was not returned for investigation, as it was discarded, and unavailable system logs prevented confirmation of the specific device used.Video review identified no use errors or system malfunctions.Biopsies were performed under live fluoroscopy, and neither the scope nor biopsy tools exceeded augmented fluoroscopy (af) boundaries.The physician did not attribute the bleeding to the galaxy system and stated that the event was related to the forceps biopsy itself, with bleeding first observed during the third biopsy.
Event or Problem Description
Bleeding was reported during a galaxy-assisted biopsy procedure and was first observed following the third forceps biopsy.The galaxy bronchoscope was retracted, and a manual scope was inserted to manage the bleed.Epinephrine and saline were administered, and suction was performed.The bleeding reportedly required approximately 15 minutes to control and was classified by the physician as a nashville grade 2 bleed.The procedure was completed, and the patient was discharged home after a short stay in the pacu.No malfunctions were reported.Attempts to gather additional patient demographics were unsuccessful.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM BRONCHOSCOPE GALB-001
• Manufacturer (Section D): NOAH MEDICAL CORP; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 23897334
• Report Number: 3021325287-2025-00076
• Device Sequence Number: 20081014
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)231103
• 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): 12/26/2025

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 Model Number: GAL-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Unknown
• Patient Weight: 54 KG
• Patient Race: White