MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION NEUROBLATE® SYSTEM

Model Number	20360
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Insufficient Heating (1287); Computer Operating System Problem (2898); Device Operational Issue (2914)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An aborted case results in the patient being unable to receive treatment.A delay in receiving treatment could allow a progression of the disease thus resulting in a death or serious injury.
Event or Problem Description
It was reported that during an ablation procedure, while the surgeon was ablating, there "seemed to be" no heating.Upon checking the laser box, the screen was completely blank and had no power.The monteris representative re-powered the laser box using the key at the box, without success.When returning to the control workstation (cws), the screen was frozen and the monteris representative had to use the task manager to exit m*vision.The representative then connected to the edcc and two errors appeared; one stated the edcc had stopped working, while the other stated that an error occurred and that technical support had to be contacted.The edcc was then restarted and the laser box was turned on.The physician continued with the ablation but with minimal heating.The case was then aborted.If additional information is received, a follow up report will be submitted.
Additional Manufacturer Narrative
Device evaluation: the device logs were evaluated and the investigator spoke with the company representative present that the case.There is a probable combination of a laser communication problem combined with a highly vascularized target area in the brain.This combination of laser communication and the vascularized area may have led the user to believe that the heating from the laser was under performing due to a system malfunction.
Event or Problem Description
Additional information received indicated that the case was aborted due to slow and minimal heating during ablation.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 6858913
• Report Number: 3009970070-2017-00136
• Device Sequence Number: 570801
• Product Code: GEX
• UDI-Device Identifier: 00816589020403
• UDI-Public: 00816589020403
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K162762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20360
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 09/12/2017
• Supplement Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other