MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20360
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the software logs were evaluation and from the screen-shots, this issue occurred before the user noticed that something was wrong.It is noted that in some acquisitions, a noise mask/thermal map was displayed in the left view, but was incorrect as it was a duplicated noise mask/thermal map of another view (either center or right-most view).It was also noted that the thermal damage lines were correct in all cases.
Event or Problem Description
It was reported that during an ablation procedure, while in treat, after the 5th pull back of the probe, the orange heat mask on the top left corner of the probe's eye view was not present.The user then re-created the trajectory, changed the master scan and eventually had to restart the software and reload the profile.There were no patient complications reported in relation to this event but it was noted that it caused a 30 minute delay to the case.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 7922535
• Report Number: 3009970070-2018-00074
• Device Sequence Number: 11159619
• Product Code: GEX
• UDI-Device Identifier: 00816589020656
• UDI-Public: 00816589020656
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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 Model Number: 20360
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1