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

Model Number	neuromate
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
After the surgery the surgeon reported an inaccuracy >2mm from the target of one electrode.The laser staple verification on the same side was offset by around 1mm.A 0.39mm frame-fit error was also reported.The patient was successfully treated.The device specification for accuracy is 2mm.This is being reported on the basis of the potential for direct harm if this were to happen on another occasion.

• 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: 50895667
• Report Number: 3009108888-2026-00007
• Device Sequence Number: 17599658
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 09/22/2025
• Initial Report FDA Received Date: 09/25/2026
• 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