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

Model Number	NEUROMATE V1.5
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); Paralysis (1997)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The neuromate stereotactic system, in conjunction with an mri guided laser ablation system from a third-party medical device manufacturer, was used to perform a laser interstitial thermal therapy (litt) surgery on (b)(6) 2025.During the procedure, radial errors were observed, with one trajectory deviating by 3mm and another by 5mm.The neuromate stereotactic system trajectories had been verified by laser verification prior to the case, confirming accurate targeting on the staple.The standard workflow involves delivering the guide screw using the neuromate stereotactic system, followed by the insertion of the laser catheter under the guide screw as part of the mri guided laser ablation system.Subsequent to the completion of the surgery on (b)(6) 2025, the surgeon reported that during the procedure, while the patient was under general anaesthesia and in the mri, the patient experienced a haemorrhage, leading to the abortion of the surgery.The patient underwent a craniotomy to evacuate the haemorrhage.They are now in the icu on a ventilator and are experiencing paralysis on the left side of their body due to the haemorrhage but can follow commands briskly on the right side.Their condition is currently stable.This report does not constitute an admission or a conclusion by the fda, renishaw mayfield sarl, or its employees that the device, renishaw mayfield sarl, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.An investigation is needed to ascertain whether there is a direct connection between the incident and the neuromate stereotactic system.
Additional Manufacturer Narrative
The robot was verified with multiple staples to confirm position accuracy of the robot.Device was within calibration specification.The robot delivers the external anchor bolt only into the scull, the rest of the procedure follows the visulase mri-guided laser ablation system workflow.The final positioning of the device in the brain is related to this device not the robot.The clinician stated they believed the issue was related to the workflow not the robot.
Event or Problem Description
The neuromate stereotactic system, in conjunction with an mri guided laser ablation system from a third-party medical device manufacturer, was used to perform a laser interstitial thermal therapy (litt) surgery on (b)(6) 2025.During the procedure, radial errors were observed, with one trajectory deviating by 3mm and another by 5mm.The neuromate stereotactic system trajectories had been verified by laser verification prior to the case, confirming accurate targeting on the staple.The standard workflow involves delivering the guide screw using the neuromate stereotactic system, followed by the insertion of the laser catheter under the guide screw as part of the mri guided laser ablation system.Subsequent to the completion of the surgery on (b)(6) 2025, the surgeon reported that during the procedure, while the patient was under general anaesthesia and in the mri, the patient experienced a haemorrhage, leading to the abortion of the surgery.The patient underwent a craniotomy to evacuate the haemorrhage.They are now in the icu on a ventilator and are experiencing paralysis on the left side of their body due to the haemorrhage but can follow commands briskly on the right side.Their condition is currently stable.This report does not constitute an admission or a conclusion by the fda, (b)(6), or its employees that the device, (b)(6), or its employee caused or contributed to the event described in the report.

• 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: 21431159
• Report Number: 3009108888-2025-00003
• Device Sequence Number: 4606115
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: NEUROMATE V1.5
• Device Catalogue Number: 001.0050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Disability
• Patient Sex: Unknown