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

Model Number	NEUROMATE V1.5
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This issue occurred in valencia, spain, but is being documented as a precautionary measure because it involves a device that has been cleared in the us and meets the reporting requirements according to cfr 803.50 (2).During a litt (laser interstitial thermal therapy) surgery where the patient was under anaesthetic, an inaccuracy was observed.The inaccuracy observed was 20mm.The surgery was cancelled.The cause of the inaccuracy has not been determined yet.The possible impact of this inaccuracy is that it could cause damage if unintended structures are passed through, if it were to reoccur, and the incorrect part of the brain may be operated on.Although 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.
Event or Problem Description
This issue occurred in valencia, spain, but is being documented as a precautionary measure because it involves a device that has been cleared in the us and meets the reporting requirements according to cfr 803.50 (2).During a litt (laser interstitial thermal therapy) surgery where the patient was under anaesthetic, an inaccuracy was observed.The inaccuracy observed was 20mm.The surgery was cancelled.The cause of the inaccuracy has not been determined yet.The possible impact of this inaccuracy is that it could cause damage if unintended structures are passed through, if it were to reoccur, and the incorrect part of the brain may be operated on.Although 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; lyon, 69680 ; FR 69680
• Manufacturer Contact: ruth rusling ; 31 rue ampére; chassieu, 69680 ; FR 69680
• MDR Report Key: 20742646
• Report Number: 3009108888-2024-00002
• Device Sequence Number: 8755393
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2024

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
• 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: 11/21/2024
• Supplement Report FDA Received Date: 12/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown