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

Model Number	NEUROMATE
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system crashed due to a corrupted file being created during patient images loading.Retrospective reporting of issue following fda inspection - documented internally in corresponding capa.
Event or Problem Description
During surgery, a patient was under anaesthesia, additional images were being imported following a scan with an o arm to collect the 3d neurolocate image series to allow registration of the patient to the robot coordinates.The neuroinspire software within the robot system brought up an error message.Following attempts to restart the pc and transfer the images from pacs and usb stick the images would still not upload so surgery was cancelled.No harm to patient but medical intervention required to close patient with no clinical benefit.Patient recovered from ga.3d neurolocate not available for sale in the usa, but the image upload issue is unlikely to be due to the use of 3d neurolocate.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: 22395325
• Report Number: 3009108888-2025-00009
• Device Sequence Number: 9024568
• 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
• 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: 11/18/2024
• 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