MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20980
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
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.This mdr is being submitted conservatively to document the identified melt and associated potential for laser emission.
Event or Problem Description
During an ablation procedure on (b)(6) 2026, a cooling error was reported that prevented initial probe cooling.The issue was resolved by swapping to a backup portable connector module (pcm) and spare laser fiber cable, after which the case proceeded without further issue.No patient injury was reported.The original complaint was evaluated and determined to be non-reportable.During investigation of the returned pcms that was received on 19-feb-2026, a melt was identified on the laser connector of one of the backup pcms that was used to troubleshoot the issue.The clinical specialist confirmed that this melt was not related to the described cooling error as this pcm's laser connection was not connected to a probe or used to fire the neuroblate laser for this case.The melt was identified incidentally during product visual inspection as part of the original complaint's investigation.The identified melt on the pcm laser connector raises the possibility of a potential unintended laser emission at an undetermined time prior to the return of the device.No patient harm related to this finding has been reported.

• 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: 24476464
• Report Number: 3009970070-2026-00002
• Device Sequence Number: 9361200
• 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): 02/27/2026

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: 02/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2014
• 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