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	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Upon plugging in the laser probe to test during the procedure, everything was normal, with laser light emitting from only the tip of the laser probe.When the patient was positioned to isocenter of the mri, the clinical specialist noticed laser light emitting from the probe umbilicals.The laser probe was removed and replaced with a different laser probe.The defective laser probe was disposed of at the site.There were no patient complications reported in relation to this event.
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 not returned, therefore, evaluation of the device was not performed.Manufacturing records indicated that the probe met required specifications.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: dan hoseck ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 16521880
• Report Number: 3009970070-2023-00004
• Device Sequence Number: 19412271
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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: 06/22/2024
• Device Model Number: 20891-000
• Device Catalogue Number: NBP-000-01
• Device Lot Number: 12177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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