MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Model Number	GALB-001
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Laceration(s) (1946); Bronchial Hemorrhage (4456)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A malfunction of scope buckling, connector issue, and wired controller unintended motion was reported with this complaint.Failure analysis investigation of the wired controller logs was performed.The logs indicated that controller commands were being sent to the biopsy tool within the scope.The generated tension within the scope was released when the biopsy tool was removed.This caused the scope to move to its commanded bend angle.The system functioned as expected following the commands of the wired controller.Failure analysis investigation of the scope was performed.Findings showed that the scope tip was pushed back by the biopsy tool and articulated by itself to a big angle due to stress relief and tool removal.This confirms the findings in the wired controller logs.Failure analysis of the bronchoscope connector was performed.Findings show that the connector was likely dislodged following removal of the scope guide from the bronchoscope connector.Video logs were reviewed and a user error is being investigated.The cause of the injury is the altered scope shape due to the biopsy tool being commanded while inside the scope.This led to the scope to articulate to its commanded bend angle.The user error is under investigation.The complaint is reported due to the following: during a galaxy-assisted biopsy procedure, the patient had bronchial tear and bleeding.The injury was treated with flexible bronchoscope wedge, balloon tamponade, chest tube, and cold saline irrigation.The physician attributes the injury to the scope.
Event or Problem Description
It was reported that while undergoing a galaxy-assisted biopsy procedure of a lesion, the patient developed bronchial tear and bleeding.The injury required treatment of flexible bronchoscope wedge, balloon tamponade, chest tube, and cold saline irrigation.The physician attributes the injury to the scope, which he claims had an aberrant shape and movement which led to the injury.Attempts to collect patient demographic information were unsuccessful.
Event or Problem Description
It was reported that while undergoing a galaxy-assisted biopsy procedure of a lesion, the patient developed bronchial tear and bleeding.The injury required treatment of flexible bronchoscope wedge, balloon tamponade, chest tube, and cold saline irrigation.The physician attributes the injury to the scope, which he claims had an aberrant shape and movement which led to the injury.Attempts to collect patient demographic information were unsuccessful.
Additional Manufacturer Narrative
A malfunction of scope buckling, connector issue, and wired controller unintended motion was reported with this complaint.Failure analysis investigation of the wired controller logs was performed.The logs indicated that controller commands were being sent to the biopsy tool within the scope.The generated tension within the scope was released when the biopsy tool was removed.This caused the scope to move to its commanded bend angle.The system functioned as expected following the commands of the wired controller.Failure analysis investigation of the scope was performed.Findings showed that the scope tip was pushed back by the biopsy tool and articulated by itself to a big angle due to stress relief and tool removal.This confirms the findings in the wired controller logs.Failure analysis of the bronchoscope connector was performed.Findings show that the connector was likely dislodged following removal of the scope guide from the bronchoscope connector.Video logs were reviewed and a user error is being investigated.The cause of the injury is the altered scope shape due to the biopsy tool being commanded while inside the scope.This led to the scope to articulate to its commanded bend angle.The user error is under investigation.The complaint is reported due to the following: during a galaxy-assisted biopsy procedure, the patient had bronchial tear and bleeding.The injury was treated with flexible bronchoscope wedge, balloon tamponade, chest tube, and cold saline irrigation.The physician attributes the injury to the scope.Supplemental: update b4: date of report update g6: follow up follow up number: 1 update h11: additional investigation revealed a use error: the biopsy tool was not withdrawn gently.However, this does not alter our conclusion that the injury resulted from the scope being manipulated while the tool remained within its lumen.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM
• 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: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 20797905
• Report Number: 3021325287-2024-00018
• Device Sequence Number: 12736209
• Product Code: EOQ
• UDI-Device Identifier: 00850048825000
• UDI-Public: 010085004882500010202408060117250200
• 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,Followup
• Report Date (Section B): 07/23/2025

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 Expiration Date: 02/01/2025
• Device Model Number: GALB-001
• Device Lot Number: 2024080601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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
• Patient Sex: Unknown