MAUDE Adverse Event Report: NOAH MEDICAL INC. GALAXY SYSTEM; GALAXY SYSTEM - BRONCHOSCOPE

Catalog Number	GALB-001
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Poor Quality Image (1408)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2024, the patient was undergoing a biopsy procedure for a 13 mm lesion in the left upper lobe when a pneumothorax was reported during the procedure.The use of the galaxy was aborted and the physician proceeded with a manual approach to complete the procedure.A chest tube was placed, the patient was admitted for an overnight stay and discharged the next day in good condition.The product was returned for investigation.The investigation identified for the camera graphics issue found that the scope was working as intended with no noticeable defects.The scope tension issue was also investigated and found that the scope articulates and relaxes in all directions with no tension warnings.The investigation concluded that the scope had no defects and is working as intended.
Event or Problem Description
On (b)(6) 2024, the patient was undergoing a biopsy procedure for a 13 mm lesion in the left upper lobe when a pneumothorax was reported during the procedure.The use of the galaxy was aborted and the physician proceeded with a manual approach to complete the procedure.A chest tube was placed, the patient was admitted for an overnight stay and discharged the next day in good condition.Information provided suggests that the use of the galaxy was not aborted due to the injury, but due to the limitations of the current scope would not reach the area the physician is targeting.The injury was attributed to the "shovel tip" design of the catheter while using the scope.During the procedure, they encountered issues with the camera graphics and scope tension.The product was returned for investigation.The product was reviewed for the camera graphics issue and found that they were working as intended with no noticeable defects.The scope tension issue was also investigated and investigation concluded that the scope articulates and relaxes in all directions, no tension warnings, and no hardware defects found.Although investigation findings concluded that injury was not caused by the galaxy system, the involvement of the galaxy system in this case led to the decision to report.The initial submission was made (b)(6) 2024, additional attempt made 28oct2024.Support from emdr helpdesk received a resubmission requested.

• Brand Name: GALAXY SYSTEM
• Common Device Name: GALAXY SYSTEM - BRONCHOSCOPE
• Manufacturer (Section D): NOAH MEDICAL INC.; 2075 zanker road; san jose CA 95131
• Manufacturer (Section G): NOAH MEDICAL INC.; 2075 zanker road; san jose CA 95131
• Manufacturer Contact: patricia apps ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 20730364
• Report Number: 3021325287-2024-00009
• Device Sequence Number: 8941379
• Product Code: EOQ
• UDI-Device Identifier: 00850048825000
• UDI-Public: 010085004882500010202407180117250100
• 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): 11/19/2024

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: 01/01/2025
• Device Catalogue Number: GALB-001
• Device Lot Number: 2024071801
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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: 39 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White