MAUDE Adverse Event Report: Noah Medical Corp. Galaxy System; Galaxy System Bronchoscope

Catalog Number	GALB-001
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	Bronchial Hemorrhage (4456)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a galaxy-assisted bronchoscopy procedure, the physician navigated to a 20 mm left upper lobe (lul) lesion following registration and tilt+ imaging.The physician performed two needle biopsy passes and one forceps biopsy pass, after which bronchial bleeding was observed.The physician treated the bleeding using a balloon and cold saline.After treatment of the bleeding, the physician prepared to obtain additional samples and resumed navigation.During navigation, an "awaiting camera signal" message appeared, followed several seconds later by a scope attached during e-stop alert.An additional alert was reportedly displayed but could not be recalled at the time of the initial complaint.The issue appeared to be scope-related, and the physician expressed concern that the issue could have had a greater clinical impact had it occurred while the bleeding was being managed.Due to this concern, the physician elected not to obtain additional samples.System error alert 10028 was subsequently displayed and could not be recovered.The clinical representative performed a hard shutdown, waited approximately five minutes, and restarted the system.No further issues were reported.The procedure was completed.Attempts to gather additional patient demographics were unsuccessful.
Additional Manufacturer Narrative
Additional details provided by the clinical representative confirmed that the bronchial bleeding was characterized as moderate, with an estimated blood loss of approximately 30ml.The bleeding was controlled using cold saline and balloon tamponade for approximately five minutes.The patient experienced no clinical instability related to the bleeding and did not require hospitalization.The physician attributed the bleeding to the biopsy procedure and did not attribute the event to the galaxy system.No patient-specific factors were identified as contributing to the bleeding, however, the lesion was reported to be located near several blood vessels.The system alerts occurred approximately two minutes after the bleeding had been completely controlled.The scope attached during e-stop alert and system error alert 10028 did not occur during active bleeding and did not interfere with treatment of the bleeding or cause a delay in patient management.No other malfunctions were observed.The concomitant device reported was a j&j monarch forceps.The system was shut down following completion of the case, and no issues were reported during subsequent cases.The bronchoscope is pending return for investigation.System and bronchoscope manufacturing records were reviewed and found no issues associated with this case.Manufacturing records were reviewed and confirmed bronchoscope passed the final qa/qc check prior to release.Video review demonstrated successful system setup, navigation, tilt+ imaging, and biopsy activity near the lul target, followed by bronchial bleeding that was managed with irrigation, suction, and a tool consistent with the reported balloon.After the bleeding had been controlled, the user attempted to resume sampling and subsequently encountered "awaiting camera signal," scope attached during e-stop alert 10023, system error alert 10028, and cart disengaged alert 10009.Log investigation determined that the alerts were caused by a loss of usb communication between the tic and idm due to instability within the usb signal chain, requiring a system restart to recover.The alerts occurred after bleeding control and did not interfere with treatment or patient care.Risk review determined that recurrence of this issue does not have the potential to result in serious injury or death.The physician attributed the bleeding to the biopsy procedure, supported by video showing bleeding following tissue sampling near a lesion located close to several blood vessels, and did not attribute the event to the galaxy system.This mdr has been submitted because the patient experienced bronchial bleeding requiring medical intervention with cold saline and balloon tamponade during a galaxy-assisted biopsy procedure.The bleeding was characterized as moderate, with approximately 30 ml of blood loss, and required intervention to control the event and prevent further harm.The physician attributed the bleeding to the biopsy procedure and did not attribute the event to the galaxy system.The subsequently observed galaxy system alerts occurred after the bleeding had been controlled and did not interfere with bleeding management or patient care.

• Brand Name: Galaxy System
• Common Device Name: Galaxy System Bronchoscope
• 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: michael chibbaro ; 2075 zanker road; san jose, CA 95131
• MDR Report Key: 50488376
• Report Number: 3021325287-2026-00042
• Device Sequence Number: 10204572
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)240722
• 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): 08/27/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: GALB-001
• Device Lot Number: 6026042002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: J&J Monarch Forceps
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 111 LB
• Patient Race: Black Or African American