MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE OPTIC FULLFIRE® LASER PROBE

Model Number	20893-000
Medical Device Problem Code	Radiation Leak (1357)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The neuroblate system insturctions 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" "to avoid equipment damage and patient injury, do not continue to deliver laser energy if no elevation in tissue temperature is observed." "a non-existent or weak visible laser aiming beam may be an indication of an improperly connected laser fiber.If this condition occurs, do not continue as it may result in equipment damage or injury to patient." 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, and the event description provided by the clinical specialist indicates that these instructions for risk mitigation were followed.Therefore, these risk mitigations remain effective.A supplementary mdr will be submitted once the product is returned and the investigation of the product is complete.
Event or Problem Description
During an ablation procedure, it was reported that a laser probe was damaged and the pilot light was seen exiting near the connector.The laser probe was not used during the case.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" -"to avoid equipment damage and patient injury, do not continue to deliver laser energy if no elevation in tissue temperature is observed." -"a non-existent or weak visible laser aiming beam may be an indication of an improperly connected laser fiber.If this condition occurs, do not continue as it may result in equipment damage or injury to patient." 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, and the event description provided by the clinical specialist indicates that these instructions for risk mitigation were followed.The red pilot light on the probe was intended to be a risk mitigator, and the probe was not used on the patient when the pilot light did not exit at its intended spot.Therefore, the device performed as intended.
Event or Problem Description
During an ablation procedure, it was reported that a laser probe was damaged and the pilot light was seen exiting near the connector.The laser probe was not used during the case.There were no patient complications reported in relation to this event.

• Brand Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Common Device Name: NEUROBLATE OPTIC FULLFIRE® 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 55403
• MDR Report Key: 17221319
• Report Number: 3009970070-2023-00019
• Device Sequence Number: 14199441
• Product Code: GEX
• UDI-Device Identifier: 00816589020953
• UDI-Public: 00816589020953
• 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,Followup
• Report Date (Section B): 08/08/2023

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: 09/28/2024
• Device Model Number: 20893-000
• Device Catalogue Number: DTP-000-01
• Device Lot Number: M0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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