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

Model Number	NEUROMATE V1.5
Medical Device Problem Code	Imprecision (1307)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a seeg (stereoelectroencephalography) surgery whilst the patient was under a general anaesthetic, some inaccuracies of between 1.70mm (within manufacturers specification) to 2.40mm (outside of manufacturers specification) of the electrode placement was observed.Note that not all of the trajectories were off target in this case.The inaccuracies were accepted by the surgeon as acceptable to proceed to with the surgery, this is because the seeg surgery is to target a region within the brain, therefore accuracy is less critical.The surgery was successfully completed and the patient was successfully treated.The cause of the inaccuracy has yet to be determined.A possible impact of an inaccuracy of this nature is that it could cause damage if unintended structures are passed through, and an incorrect part of the brain may be operated on if this situation was to reoccur under different circumstances.Although it is unlikely that this issue could result in death or serious injury, there is a potential in the worst case scenario.
Additional Manufacturer Narrative
Summary of investigation: an investigation into the issue was conducted, revealing that the accuracy of the neuromate system fell within the manufacturer's specifications (maximum error of 0.370mm).Following a subsequent procedure on (b)(6) 2025, a note from the surgeon indicated that the accuracy performance "went very well." it has been concluded that the neuromate device was not responsible for the inaccuracies observed on (b)(6) 2025.
Event or Problem Description
During a seeg (stereoelectroencephalography) surgery whilst the patient was under a general anaesthetic, some inaccuracies of between 1.70mm (within manufacturers specification) to 2.40mm (outside of manufacturers specification) of the electrode placement was observed.Note that not all of the trajectories were off target in this case.The inaccuracies were accepted by the surgeon as acceptable to proceed to with the surgery, this is because the seeg surgery is to target a region within the brain, therefore accuracy is less critical.The surgery was successfully completed and the patient was successfully treated.The cause of the inaccuracy has yet to be determined.A possible impact of an inaccuracy of this nature is that it could cause damage if unintended structures are passed through, and an incorrect part of the brain may be operated on if this situation was to reoccur under different circumstances.Although it is unlikely that this issue could result in death or serious injury, there is a potential in the worst case scenario.

• 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: 21431179
• Report Number: 3009108888-2025-00002
• Device Sequence Number: 11913773
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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
• Device Model Number: NEUROMATE V1.5
• Device Catalogue Number: 001.0050
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 03/27/2025
• 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: Other
• Patient Sex: Unknown