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

Model Number	NEUROMATE
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A robot inaccuracy of ~3mm was detected during registration of the patient to robot space as detected on a registration staple.The surgeon therefore amended the trajectory by the offset to ensure that the device was placed where intended.There was no issue seen with the final placement of the device.If the inaccuracy were to happen again, under different circumstances and the clinician did not correct for the offset seen, the possible impact is that it could cause damage if unintended structure are passed through, and an incorrect part of the brain may be operated on.Although it it is unlikely that this issue could result in death or serious injury, there is a potential for such an outcome in the worst-case scenario.
Additional Manufacturer Narrative
Plan was reviewed and showed final trajectory deviation of less than 2mm.Robot intrinsic and frame-based accuracy was verified.All were within specifications.Patient shifting most likely led to staple verification point to be displaced while the robot was still in good accuracy.
Event or Problem Description
A robot inaccuracy of ~3mm was detected during registration of the patient to robot space as detected on a registration staple.The surgeon therefore amended the trajectory by the offset to ensure that the device was placed where intended.There was no issue seen with the final placement of the device.If the inaccuracy were to happen again, under different circumstances and the clinician did not correct for the offset seen, the possible impact is that it could cause damage if unintended structure are passed through, and an incorrect part of the brain may be operated on.Although it it is unlikely that this issue could result in death or serious injury, there is a potential for such an outcome 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: 22714013
• Report Number: 3009108888-2025-00011
• Device Sequence Number: 21124429
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/18/2025
• 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