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

Model Number	20893-000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, the user had been stepping on pedal to activate laser, but no tdt lines were formulating.The attending clinical specialist told user to stop and went into mri room and noticed white probe cabling was burnt.The user was able to proceed with the case.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
The product was visually inspected upon return.The cause of the event could not be confirmed.

• Brand Name: NEUROBLATE OPTIC FULLFIRE LASER PROBE
• Common Device Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th avenue n; suite c; plymouth MN 55447
• MDR Report Key: 10683237
• Report Number: 3009970070-2020-00082
• Device Sequence Number: 16425958
• 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: K193375
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 08/25/2022
• Device Model Number: 20893-000
• Device Catalogue Number: DTP-000-01
• Device Lot Number: D3191-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1