MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20980
Medical Device Problem Code	Radiation Leak (1357)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The neuroblate system instructions for use contain laser safety warnings as risk mitigations for this event: section 4.3, general warnings: "laser eye protection provided with the neuroblate system must be worn in the mri scanner room during operation of the laser" section 4.6, laser safety warnings: "ensure the laser fiber connections are made correctly.Improper connections may lead to equipment damage or operator injury." section 4.7, inspection, cleaning, disinfection, sterilization: "prior to use: carefully inspect all system laser cable/umbilical connections to ensure they have all completed the "two-click" connection, i.E., plug is pushed into mating connector so that one click at partial (half) insertion and a second click at full insertion." no harm was observed in this event.
Event or Problem Description
During an ablation procedure on (b)(6) 2026, it was reported that the laser probe failed to generate adequate thermal energy.The laser fiber from the pen panel to the portable connector module (pcm) was replaced, but no change in performance was observed.The laser probe itself was then replaced, after which heat generation was slightly improved, though it was still noted to be slower than expected.No patient complications were reported in relation to this event.On (b)(6) 2026, an on-site investigation was performed and field personnel identified a damage with burn marks on the primary laser fiber that ran from the electronics rack to the mri room, implying a potential unwanted laser emission during the case on (b)(6) 2026.The damaged fiber was replaced during the on-site investigation.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: michelle bergstrom ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 24776110
• Report Number: 3009970070-2026-00003
• Device Sequence Number: 9888783
• Product Code: GEX
• UDI-Device Identifier: 00816589021080
• UDI-Public: 00816589021080
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K193375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/01/2026

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: 20980
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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