MAUDE Adverse Event Report: NOAH MEDICAL GALAXY SYSTEM

Catalog Number	GALB-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2024, a pneumothorax incident was reported in a patient.Following the adverse event, an investigation was conducted to determine if any malfunctions or manufacturer-related factors could have contributed to the incident.The user noted a malfunction involving em signal loss during the procedure, which was observed after the tilt sweep.Em signal loss lasted for 54 seconds.It may have been due to the interference from c-arm, sampling biopsy tool, or an unknown environmental factor.It does not appear to have caused the adverse event and hence the investigation was broadened to assess other possible causes.The returned bronchoscope device was evaluated in-house to replicate the reported issue.The staff engineer was unable to replicate the issue and found the bronchoscope to be functioning as expected.Additionally, the investigation concluded that there was no unintended motion of the idm.The engineer did not find any scope motion like articulation/retraction during sampling.In conclusion, the galaxy system functioned as expected.No root cause that could have caused/contributed to the event was found.The physician attributed the pneumothorax event to the lesion location and partially to the use of noah's galaxy system.It is acknowledged that the potential for a pneumothorax is an inherent risk associated with bronchoscopy procedures, and this risk is duly documented in noah medical's risk file.Ongoing tracking and trending of such incidents will be maintained to facilitate continuous improvement and risk management strategies.
Event or Problem Description
During a galaxy-assisted bronchoscopy procedure, a pneumothorax was reported in the patient.Although the physician noted em signal loss during the procedure, an investigation of the logs and an evaluation of the returned device concluded that the noah medical device did not cause or contribute to the event.However, the physician partially attributed the injury to the galaxy system.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM
• Manufacturer (Section D): NOAH MEDICAL; 2075 zanker road; san jose; CA 95131
• Manufacturer (Section G): NOAH MEDICAL; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: andrea mahoney ; 2075 zanker road; san jose, CA 95131 ; 9257195043
• MDR Report Key: 20140766
• Report Number: 3021325287-2024-00007
• Device Sequence Number: 20698600
• Product Code: EOQ
• UDI-Device Identifier: 00850048825000
• UDI-Public: 010085004882500010202406180117241200
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: 12/17/2024
• Device Catalogue Number: GALB-001
• Device Lot Number: 2024061801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White