MAUDE Adverse Event Report: Renishaw Mayfield SARL Neuromate Gen III Stereotactic System

Model Number	neuromate
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a follow-up field service engineer visit after a seeg procedure, the surgeon reported that a post-operative mri had identified a blood clot.Patient was transferred from recovery room back to operating theatre.One electrode was removed to allow the blood clot to be removed.The surgeon advised that the finding had been treated successfully and that there was no current concern regarding the patient's condition.The surgeon stated that he did not believe the finding was related to robot accuracy.During the procedure, robot accuracy had been verified using the staple method and no concerns were identified.The surgeon requested a discussion regarding procedural factors that may influence electrode delivery.Reporting on the basis of presence of a blood clot viewed on the scan following the procedure and the return of the patient to surgery to remove an implanted electrode allowing removal of the clot.No evidence from the clinician that this was related to the use of the robot.

• 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: rusling ; 31 rue ampere, ,; chassieu, 69680 ; FR 69680
• MDR Report Key: 50915885
• Report Number: 3009108888-2026-00009
• Device Sequence Number: 17587094
• 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,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/28/2026
• 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