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

Model Number	20893-00
Medical Device Problem Code	Radiation Leak (1357)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The neuroblate system instructions for use, revision b (current) contains 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" no harm was observed in this event or any previously reported 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
It was reported that the laser fiber pilot light was low prior to the start of the ablation procedure.No visible breaks or structural damage to the fiber were noticed at the time of the event.Additionally, no visual leakage of pilot light onto umbilical was observed at the time of the event.

• Brand Name: NEUROBLATE OPTIC FULLFIRE SELECT® LASER PROBE
• Common Device Name: NEUROBLATE OPTIC FULLFIRE SELECT® LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer (Section G): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: jordon honeck ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 13384681
• Report Number: 3009970070-2022-00003
• Device Sequence Number: 11682398
• Product Code: GEX
• UDI-Device Identifier: 00816589020946
• UDI-Public: 00816589020946
• 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): 01/28/2022

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: 04/01/2023
• Device Model Number: 20893-00
• Device Catalogue Number: DTP-001-101
• Device Lot Number: 10899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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