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

Model Number	NEUROMATE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
3 surgeries were planned for 24th november: dbs, seeg and litt.Following a collision between the robot arm and another piece of surgical equipment in the first surgery the clinician continued with the surgeries planned for the rest of the day.Subsequent surgeries showed inaccuracies in trajectory, leading to the second surgery having a 3-4mm inaccuracy and the 3rd surgery being cancelled.Dbs - very good accuracy on verification trajectory (on the leksell frame) and during the surgery.At the end of the surgery the robot apparently collided with a surgical separator and got blocked (lost connection).The clinician managed to regain the control of the arm and insists the collision/contact was very light.Seeg (9 electrodes) - verification trajectory showed a 3-4mm error and the surgeon decided to proceed with the surgery.The same error was confirmed during surgery (error on all trajectories in the same direction).Clinician puts seeg fixation screws first and then if accuracy is acceptable implants the electrodes.Litt - surgery aborted as 3-4mm error in this type of procedure was not acceptable to the surgeon.The patient was not under ga when the surgery was cancelled.This is being reported due to the second case being outside of the manufacturers specification for accuracy.If the inaccuracy were to happen again, under different circumstances, 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: 23717888
• Report Number: 3009108888-2025-00014
• Device Sequence Number: 8900947
• Product Code: HAW
• UDI-Device Identifier: 03662724000345
• UDI-Public: 03662724000345
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 06/17/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown