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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the initial stages of the surgery before the surgeon had put knife to skin the robot got stuck in position when the surgeon tried to do the neurolocate registration to confirm the position of the patient within the robot space.The surgeon chose to continue the surgery by another means and the patient was successfully treated.In another occasion the surgeon may have had to cancel the procedure giving the patient anaesthetic with no therapeutic benefit, this is being reported on this basis of this potential indirect harm if it were to occur 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: 23863787
• Report Number: 3009108888-2025-00017
• Device Sequence Number: 10098556
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 12/10/2025
• Initial Report FDA Received Date: 12/22/2025
• 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