MAUDE Adverse Event Report: NOAH MEDICAL CORP. GALAXY SYSTEM

Medical Device Problem Code	Failure to Shut Off (2939)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after a galaxy-assisted biopsy procedure, the galaxy system did not fully shut down.The system was able to shut down after 15 minutes.There were no injuries reported or treatment administered with this case.No other malfunctions were reported.Although there were no injuries reported, this malfunction may contribute to a serious injury.
Additional Manufacturer Narrative
System manufacturing records were reviewed and found no issues associated with this case.Scope manufacturing records were reviewed and found no issues associated with this case.Preliminary investigations revealed that the behavior of the e-stop led remaining illuminated after ac power is removed from the system input indicates that the ups is continuing to power its ac outputs from its battery.The potential impact on subsequent cases after delayed shut down will result in the ups not charging sufficiently to support the following cases in the event of a power failure.No other malfunctions were reported.This malfunction is being reported due to the following conclusions: during a galaxy-assisted biopsy procedure, the user experienced the system not being able to shut down.Investigation findings revealed that this failure increased the probability of a severe injury from a frequency from 2 (remote) - 4 (probable).No injuries or treatment were reported in this case.
Event or Problem Description
It was reported that after a galaxy-assisted biopsy procedure, the galaxy system did not fully shut down.The system was able to shut down after 15 minutes.There were no injuries reported or treatment administered with this case.No other malfunctions were reported.Although there were no injuries reported, this malfunction may contribute to a serious injury.
Additional Manufacturer Narrative
System manufacturing records were reviewed and found no issues associated with this case.Scope manufacturing records were reviewed and found no issues associated with this case.Preliminary investigations revealed that the behavior of the e-stop led remaining illuminated after ac power is removed from the system input indicates that the ups is continuing to power its ac outputs from its battery.The potential impact on subsequent cases after delayed shut down will result in the ups not charging sufficiently to support the following cases in the event of a power failure.No other malfunctions were reported.This malfunction is being reported due to the following conclusions: during a galaxy-assisted biopsy procedure, the user experienced the system not being able to shut down.Investigation findings revealed that this failure increased the probability of a severe injury from a frequency from 2 (remote) - 4 (probable).No injuries or treatment were reported in this case.Update h11: initial preliminary investigation findings suggest that the malfunction of the ups may increase the likelihood of severe injury (bleeding, major) from a frequency of 2 (remote) to 4 (probable).However, following a further risk assessment review, it has been determined that the most likely risk associated with ups issues is an aborted procedure, with a probability of 3 (occasional).While the severity of the initial risk of bleeding, major remains at 3 (serious), the probability has been reassessed to 1 (improbable).Therefore, the complaint is deemed non-reportable.

• 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: 21428239
• Report Number: 3021325287-2025-00010
• Device Sequence Number: 4528418
• Product Code: EOQ
• UDI-Device Identifier: 00850048825048
• UDI-Public: (01)00850048825048(11)230516
• 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,Followup
• Report Date (Section B): 04/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Race: White