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

Model Number	20895-5
Medical Device Problem Codes	Radiation Leak (1357); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During an ablation procedure, it was reported that cooling began and confirmed cool pixels appearing in thermal mask.User began firing the laser at the workstation, and after the clinical specialist saw no change in thermal mask after several measurements, the clinical specialist asked to user to stop firing.Upon inspection of laser at back of bore, an odor of smoke was immediately detected, and a charred point on the laser umbilicals was found.Laser was replaced and ablation resumed.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Break in probe laser fiber identified during inspection activities on (b)(6) 2021.(b)(6) 2021 is when information became available to meet the mdr reportability criteria and is therefore considered the reportability decision date.The dhr for this lot was reviewed and it was found that all probes in the lot passed all laser tests prior to release.The neuroblate system insturctions 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." 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.

• 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: 13191300
• Report Number: 3009970070-2022-00001
• Device Sequence Number: 5935258
• Product Code: GEX
• UDI-Device Identifier: 00816589021073
• UDI-Public: 00816589021073
• 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): 01/07/2022

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: 07/08/2023
• Device Model Number: 20895-5
• Device Catalogue Number: FFS522-01
• Device Lot Number: 11346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2021
• 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