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

Model Number	20893-000
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure, it was reported that the physician started pressing the foot pedal once he was ready to ablate.After a few acquisitions, the clinical specialist noticed that there was no heat observed in the thermal mask.The clinical specialist suggested to the physician to step off the pedal and went to investigate.Upon entering the mri suite to check the e2k connection between the laser and the portable connector module (pcm), the clinical specialist tried to unplug and re-plug the laser fiber but was unsuccessful.When attempting to unplug the laser fiber from the e2k connection, the orange tab of the laser fiber broke off.At this time, the clinical specialist gathered the cable and the found that the e2k-to-e2k connection of the pcm and the fiber was fused.Given the situation, a new fiber was obtained and the pcm was replaced with a new one.After doing so, the ablation procedure was resumed and the lesion was successfully ablated.There were no patient complications reported in relation to this event.
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" 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 damage was confirmed.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.

• 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: austin irwin ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 16904083
• Report Number: 3009970070-2023-00014
• Device Sequence Number: 5459086
• 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
• Report Date (Section B): 05/10/2023

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: 10/04/2024
• Device Model Number: 20893-000
• Device Catalogue Number: DTP-000-01
• Device Lot Number: 12560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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