MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Catalog Number	CRB-1549
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that during a galaxy-assisted bronchoscopy procedure in january, following forceps biopsies, the physician noticed a clot.While attempting to remove the clot with forceps, the physician briefly experienced a loss of vision due to the clot.The patient later experienced bleeding.To manage the bleeding, the physician used a fogarty balloon to tamponade for a few minutes, sprayed epinephrine through the scope, and cleaned both lungs.The patient was subsequently hospitalized in the pacu, where they recovered and were later discharged.The physician did not attribute the bleeding to the use of the galaxy device but rather to the biopsy procedure and clot dislodgement.No malfunctions of the galaxy device were reported during the procedure.A clinical engineer reviewed the procedure video logs and found no user errors or malfunctions of the noah galaxy device that could have caused or contributed to event.
Event or Problem Description
It was reported that during a galaxy-assisted bronchoscopy procedure in january, following forceps biopsies, the physician noticed a clot.While attempting to remove the clot with forceps, the physician briefly experienced a loss of vision due to the clot.The patient later experienced bleeding.To manage the bleeding, the physician used a fogarty balloon to tamponade for a few minutes, sprayed epinephrine through the scope, and cleaned both lungs.The patient was subsequently hospitalized in the pacu, where they recovered and were later discharged.The physician did not attribute the bleeding to the use of the galaxy device but rather to the biopsy procedure and clot dislodgement.No malfunctions of the galaxy device were reported during the procedure.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM
• Manufacturer (Section D): NOAH MEDICAL CORP.; 2075 zanker road; san jose 95131
• Manufacturer (Section G): NOAH MEDICAL CORP.; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 21369324
• Report Number: 3021325287-2025-00006
• Device Sequence Number: 8482228
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: 010085004882504811240624
• 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): 02/14/2025

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 Catalogue Number: CRB-1549
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White