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

Model Number	NEUROMATE
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a dbs, neuroinspire indicated a com fault.After this, the operating room pc shut down, and it was unable to be powered back on.The pc tower power light would turn on, the cd-rom light would flash, the monitor would display a no dp signal message, and the pc would then shut off.The surgeon had to finish the case via arc & frame.The or pc was attempted to be turned on several times, including multiple charge releases.Following completion of the surgery, the pc turned back on.In another occasion the surgeon may have had to cancel the procedure giving the patient anaesthetic with no therapeutic benefit, this is being reported on this basis of this potential indirect harm if it were to occur on another occasion.

• 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: rusling ; 31 rue ampere, ,; chassieu, 69680 ; FR 69680
• MDR Report Key: 25595222
• Report Number: 3009108888-2026-00003
• Device Sequence Number: 5481913
• Product Code: HAW
• UDI-Device Identifier: 03662724000444
• UDI-Public: 03662724000444
• 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
• Type of Report: Initial
• Report Date (Section B): 06/23/2026

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: 001.0119
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 06/23/2026
• 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