MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20891-000
Medical Device Problem Code	Radiation Leak (1357)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
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.".Product was returned and the event was able to be replicated.Manufacturing records indicated that the probe met required specifications.No harm was observed in this event, and the event description provided by the clinical specialist indicates that these instructions for risk mitigation were followed.Therefore, these risk mitigations remain effective.
Event or Problem Description
During a procedure, a probe was opened from its packaging and the pilot laser light was checked.The light looked visibly dim at the tip.It was then noticed that there was a light leak around the area of the depth stop adjustment.It was decided that the probe could not be used, and a second probe was opened and used without issue.There were no patient complications reported in relation to this event.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: austin irwin ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 16690493
• Report Number: 3009970070-2023-00012
• Device Sequence Number: 5921106
• Product Code: GEX
• UDI-Device Identifier: 00816589020885
• UDI-Public: 00816589020885
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182036
• 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): 04/06/2023

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 Expiration Date: 12/23/2024
• Device Model Number: 20891-000
• Device Catalogue Number: NBP-000-01
• Device Lot Number: 13142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2022
• 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