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

Model Number	NEUROMATE
Medical Device Problem Codes	Operating System Version or Upgrade Problem (2997); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The root cause analysed related to part 1 (the failure of the ultrasound registration), the neuroinspire system was unable to adequately handle the communication error in the ultrasound system, which caused neuroinspire to terminate during the registration process workflow.Improved error handling for the ultrasound registration has been incorporated in a future neuroinspire software release.Software testing has been improved to include scenarios to check for error handling.This module is not avaiable in the usa.The root cause analysed related to part 2 (windows update).The pc had an ethernet network cable plugged in (required to obtain image data from the pacs server), whilst it was connected it downloaded security updates.The restarting of the pc then triggered the installation of the windows update.Design mitigations are in place to minimise the potential for windows updates during working hours; however these can be overridden by the operating system.There are no further risk mitigations identified to prevent windows updates which override the defined scheduling.Retrospective reporting of issue following fda inspection documented internally in corresponding capa.
Event or Problem Description
The neuroinspire software was not available to complete a surgery with the patient under a general anesthetic at the time.The unavailability of the software was due to two separate issues: 1.The registration of the patient to the robot using the ultrasound module within the software failed on 3 occasions; and 2.Microsoft windows forced an update during surgery, which meant the clinician was unable to access the software.This resulted in a delay; therefore, the clinician took the decision to cancel the surgery.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.The ultrasound module is not available in the usa but the windows issue could occur in the version available in the usa, so is being reported even though it was not clear which issue was the cause of the cancellation of surgery.

• 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: 22395113
• Report Number: 3009108888-2025-00005
• Device Sequence Number: 15729501
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: 02/21/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown