MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Model Number	GALB-001
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Video logs were reviewed, and user errors were observed from procedure recording.The user removed the scope from the patient without disconnecting it from the idm.Failure analysis investigation of the scope was performed.Physical inspection of the scope revealed a bend at the junction of the bending section and the laser cut shaft, causing segment separation at the proximal end of the bending section.A kink on the shaft was formed and wrinkle on the surrounding outer jacket.This is confirmed to be due to the scope being removed from the patient without disconnecting from the idm.Failure analysis of the system logs and controller logs were performed.The controller, idm, and software were behaving as expected.The unresponsive behavior in articulation is due to scope being damaged due to the user error during the procedure.This resulted in poor response to articulation commands.The cause of the injury is due to the scope prematurely removed from the patient.The complaint is reported due to the following conclusions: during a galaxy-assisted biopsy procedure, the patient had bleeding and was treated with ice cold saline.Since the cause of the injury is user error, the use of the scope contributed to the injury.
Event or Problem Description
It was reported that while undergoing a galaxy-assisted biopsy procedure of a lesion at the right upper lobe, the patient developed bleeding.Ice cold saline was administered, and additional intervention was not necessary.The physician attributes the injury to the scope and states it exhibited abnormal shapes and behavior during the procedure.Investigation determined the scope was prematurely removed from the patient.Attempts to collect patient demographic information were unsuccessful.

• 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: 20764537
• Report Number: 3021325287-2024-00015
• Device Sequence Number: 20930954
• Product Code: EOQ
• UDI-Device Identifier: 00850048825000
• UDI-Public: 010085004882500010202408140
• 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): 11/22/2024

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: 2024081402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2024
• 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: Prefer Not To Disclose