MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE NB3 FULLFIRE¿ 1.6 LASER PROBE

Model Number	22002
Medical Device Problem Code	Radiation Leak (1357)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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." no harm was observed in this event.
Event or Problem Description
During an ablation procedure, it was reported that the probe laser fiber was inserted into the patient while in the or.When the patient was positioned in the mri, the probe was plugged into the portable connector module (pcm) and the red pilot light was visible at the strain relief area of the probe.This abnormal pilot light observation was mentioned to the physician and they decided to continue with the procedure.The user attempted to fire the laser with the probe for 3 measurements, but had no heat reaching the tip of the fiber.The laser probe was replaced with a new laser probe in the mri room, and the ablation was successfully completed.There was no abnormal pilot light observation with the second laser probe.There were no patient complications reported in relation to this event.

• Brand Name: NEUROBLATE NB3 FULLFIRE¿ 1.6 LASER PROBE
• Common Device Name: NEUROBLATE NB3 FULLFIRE¿ 1.6 LASER PROBE
• 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: 21939361
• Report Number: 3009970070-2025-00004
• Device Sequence Number: 8835935
• Product Code: GEX
• UDI-Device Identifier: 00816589021585
• UDI-Public: 00816589021585
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K231061
• 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): 04/30/2025

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: 22002
• Device Catalogue Number: FFD-016
• Device Lot Number: M0674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown