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

Model Number	20891-00
Medical Device Problem Code	Radiation Leak (1357)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure, it was reported that, prior to inserting the probe through the robotic probe driver, the cooling and pilot light were checked.No issues were noted at this time.The volumetric mri scan was run, coordinates were entered, and the ablation started.For the first minute, the ablation went as planned and the probe functioned as intended.After the first minute passed, it was noted that the sidefire probe being used was not observed to be heating the targetted lesion.Since the stopping point has been reached, a new burn was started at the same point.The user began ablating again after starting the mri, with no heat being noted on the noise mask.The ablation was paused, and upon walking into the mri, the probe was inspected and a red pilot light was visible halfway up the probe wire.The probe was removed and was sent back to the monteris headquarters.A new probe was inserted, and the ablation continued without issue.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." 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.

• Brand Name: NEUROBLATE OPTIC SIDEFIRE® LASER PROBE
• Common Device Name: NEUROBLATE OPTIC SIDEFIRE® 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: 18274399
• Report Number: 3009970070-2023-00009
• Device Sequence Number: 7160250
• Product Code: GEX
• UDI-Device Identifier: 00816589020878
• UDI-Public: 00816589020878
• 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): 12/06/2023

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: 04/11/2025
• Device Model Number: 20891-00
• Device Catalogue Number: NBP-001-01
• Device Lot Number: 13150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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