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

Model Number	NEUROMATE
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgery where a patient was under general anathestic, the neuroinspire software crashed on multiple occasions, when the surgeon tried to import an mri image.The same issue occurs when trying to import a interoperative ct series done with the o-arm.As a result of this issue, the surgery was cancelled.The impact to the patient has not been confirmed, but a further surgery for this patient is scheduled for (b)(6) 2025.No harm to patient but medical intervention required to close patient with no clinical benefit.Patient recovered from ga.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.
Additional Manufacturer Narrative
Investigation is ongoing retrospective reporting of issue following fda inspection - documented internally in corresponding capa.
Additional Manufacturer Narrative
There was an issue with the runtime cache within the software which was causing the software to crash.Retrospective reporting of issue following fda inspection - documented internally in corresponding capa.
Event or Problem Description
During a surgery where a patient was under general anathestic, the neuroinspire software crashed on multiple occassions, when the surgeon tried to import an mri image.The same issue occurs when trying to import a interoperative ct series done with the o-arm.As a result of this issue, the surgery was cancelled.The impact to the patient has not been confirmed, but a further surgery for this patient is scheduled for (b)(6) 2025.No harm to patient but medical intervention required to close patient with no clinical benefit.Patient recovered from ga.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: 22395350
• Report Number: 3009108888-2025-00010
• Device Sequence Number: 15750806
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 01/30/2025
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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