MAUDE Adverse Event Report: NOAH MEDICAL INC. GALAXY SYSTEM

Catalog Number GALB-001

Device Problems Entrapment of Device (1212); Difficult to Insert (1316); Difficult to Remove (1528)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Pneumothorax (2012)

Event Date 01/17/2024

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2024, during a noah galaxy assisted bronchoscopy procedure a patient experienced bleeding, cardiac arrest, and bilateral pneumothoraces.The incident prompted a thorough investigation to understand the root causes and contributing factors.Upon reviewing the information gathered from the event and analyzing the video log, it was observed that the physician encountered challenges in navigating a difficult area within the patient's upper left lobe(lul).The physician was unable to fully reach the intended lesion location with the bronchoscope contributing to scope buckling.Throughout the procedure, there were six instances of scope buckling error notifications.Ultimately, the repeated attempts by the physician to drive the scope forward and continued acknowledgement of the scope buckling workflow inhibitor error message resulted in the creation of a kink in the bronchoscope shaft exhibiting a fishhook shape, further complicating the procedure.Extraction of the bronchoscope in the buckled and fishhook shape proved challenging, requiring the physician to manually release the bronchoscope from the robot and push and rotate until the bronchoscope tip was able to pass back through the endotracheal tube and be removed from the patient.The results of the investigation determined that the adverse event occurred due to a use error where multiple (six) acknowledgments of scope buckling error messages occurred, but the user failed to follow the on-screen and ifu instructions to utilize fluoroscopic imaging to check the shape of the scope.Each time the system error message occurred, the use of fluoroscopy was not utilized to check the condition of the bronchoscope or the cause of the scope buckling, the user acknowledged the workflow inhibitor message and proceeded forward with the case without following the on-screen and ifu instructions related to scope buckling warnings.Based on the investigation, scope buckling was not a result of device malfunction or defective scope.It was the repeated use error of dismissing the error message without performing the recommended fluoroscopy to verify the scope position that caused damage to the scope and ultimately contributed to harming the patient.Specifically, the galaxy ifu (10000752 rev.F) contains the following warning: "do not continue inserting the scope if scope buckling is detected.Continued insertion may result in patient injury." the on-screen error message (which is also included in the ifu alerts table) contains the following verbiage: "scope buckling detected.Please retract until scope insertion is responsive to controls, then try again.If this problem persists, please take a fluoro image to check the shape of the scope." a comprehensive investigation also included a review of the lot history record associated with the medical device used in the procedure.Notably, no deviations or non-conformances were identified for this lot.The device was manufactured and shipped in strict adherence to specifications.Because of the complications arising from the procedure, the patient is currently hospitalized.The medical team is actively monitoring and addressing the patient's condition.Patient's condition will continue to be monitored until release from the hospital and will be documented in the complaint record.

Event Description

On (b)(6) 2024, during a bronchoscopy procedure assisted by the noah galaxy system, a patient experienced bleeding, cardiac arrest, and bilateral pneumothoraces.The target lesion was located in the right upper lobe (rul).The physician attempted to navigate to the lesion using the noah medical galaxy system, the procedure was impeded due to scope buckling, resulting in a kinked scope that proved challenging to remove from the patient's body.Consequently, the patient suffered adverse events.Presently, the patient remains hospitalized as a result of complications arising from the procedure.The medical team is actively monitoring and addressing the patient's condition.For additional details, please refer to manufacturer's narrative for investigation and rootcause.

• Brand Name: GALAXY SYSTEM
• Type of Device: GALAXY SYSTEM
• Manufacturer (Section D): NOAH MEDICAL INC.; 1501 industrial rd; san-carlos, ca 94070 CA 94070
• Manufacturer (Section G): NOAH MEDICAL INC.; 1501 industrial rd; san-carlos CA 94070
• Manufacturer Contact: peter seo ; 1501 industrial rd,; san-carlos, ca 94070, CA 94070
• MDR Report Key: 18699853
• MDR Text Key: 335295469
• Report Number: 3021325287-2024-00001
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• PMA/PMN Number: K223144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GALB-001
• Device Lot Number: 2023110703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White