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

Model Number	NEUROMATE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In the robot arm the axis 5 position went under the lower limit during a trajectory planned by the software.The 5th axis is designed not to fall below 14500, the value displayed 13900.As this was below the limits the system operated as expected and blocked the request.Testing was undertaken to unlock the block and verified functional verification, verified in the link 3 that a cable was not disconnected and completed an intrinsic verification.Following this interventionthe system was operating as expected.Unable to determine a root cause for this issue.Retrospective reporting of issue following fda inspection - documented internally in corresponding capa.
Event or Problem Description
During a surgery, where the patient was under general anesthetic and open, there was an problem with the system which blocked the first trajectory being sent to the neuromate.Remediation action was taken to restart the system, but the problem persisted - therefore the surgery was cancelled.No harm to patient but medical intervention required to close patient with no clinical benefit.Patient recovered from ga.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: 22395304
• Report Number: 3009108888-2025-00008
• Device Sequence Number: 9401333
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: 03/14/2022
• 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