MAUDE Adverse Event Report: RENISHAW MAYFIELD SARL NEUROMATE GEN III STEREOTACTIC SYSTEM

Model Number	NEUROMATE
Medical Device Problem Codes	Operating System Becomes Nonfunctional (2996); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Log files from the system were retrieved and evaluated.This indicated that the system performed operating system updates on the day of the incident and that these updates were completed 1 hour after the problem occurred.Connection to the network on the day of the procedure resulted in updates being automatically downloaded and installed.The install of these os updates affected the use of the save function of the system during the procedure.The surgeon has confirmed that they use memory stick to transfer plans 90% of the time instead of pacs.They will use this method exclusively until advised differently.Retrospective reporting of issue following fda inspection documented internally in corresponding capa.
Event or Problem Description
Neuroinspire is the software in the neuromate robot system during surgery, where a patient was under general anesthetic there were issues with the plan functionality.1.Neuroinspire would not save plans with new series added.2.When neuroinspire was in recovery mode the original plan would not open.3.Unable to open any historic plans in neuroinspire.It support was provided enabling the neuroinspire session to be terminated, but plans could not be opened at all.The surgery was unable to proceed and therefore the surgery was cancelled.The surgeon needed to surgically close the patient up without being able to compete the planned surgery.This is being reported on the basis of the surgical intervention to close the patient at an unplanned stage of the surgery due to a malfunction of the device.

• Brand Name: NEUROMATE GEN III STEREOTACTIC SYSTEM
• Common Device Name: NEUROMATE GEN III
• Manufacturer (Section D): RENISHAW MAYFIELD SARL; 31 rue ampere, ,; chassieu, 69680 ; FR 69680
• Manufacturer (Section G): RENISHAW MAYFIELD SARL; 31 rue ampere, ,; chassieu, 69680 ; FR 69680
• Manufacturer Contact: ruth rusling ; 31 rue ampere, ,; chassieu, 69680 ; FR 69680
• MDR Report Key: 22395292
• Report Number: 3009108888-2025-00007
• Device Sequence Number: 9190947
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181706
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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
• Device Model Number: NEUROMATE
• Device Catalogue Number: 001.0500
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown