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

Model Number	NEUROMATE
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During a seeg surgery, the robot lost initialisation.The user had tried using the diagnostic checks to resolve the issue before phoning for support.During the diagnostic checks, the systems intermittently failed the initialisation check.The user had also installed the spare communications cable but this did not resolve the issue.The patient was under general anesthetic when this occurred, surgery was subsequently cancelled without the treatment being completed.The surgery was abandoned prior to knife to skin, and the patient suffered no ill-effect from being under anesthetic.No harm to patient and no medical intervention required.Patient just recovered from ga.This is being reported because if this had occurred on another occasion it may have been at another part of the procedure which would have required surgical intervention to close the patient at an unplanned stage before the surgery had been completed.
Additional Manufacturer Narrative
Intermittent voltage drop on the robot.Initial checks showed that voltages were low but within specification.Components were detached and reattached.The intermittent issue still occurred.In a second intervention block connectors were replaced with new contacts, and the voltage drop was not encountered any more.This robot is now fully functioning.The electrical component degraded over time causing a voltage drop, the voltage level was not sufficient enough to allow the components in the arm to function correctly.Retrospecitve reporting of issue following fda inspection - documented internally in corresponding capa.

• 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: 22395262
• Report Number: 3009108888-2025-00006
• Device Sequence Number: 9024559
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• 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: 02/07/2023
• 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