MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION FULLFIRE DIFFUSING TIP LASER PROBE; FULLFIRE¿ DIFFUSING TIP LASER PROBE

Catalog Number	FFS002-01
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, there was unintended probe heating.There were no patient complications reported in relation to this event.If additional information is received, a follow up report will be submitted.
Additional Manufacturer Narrative
Device evaluation: review of the software logs were performed.A probe temperature was recorded in the hardware log files which showed evidence of possible unintended heating of the probe.
Event or Problem Description
Additional information received indicated that the patient had no adverse events.The patient is now deceased but the death is not attributed to neuroblate.

• Brand Name: FULLFIRE DIFFUSING TIP LASER PROBE
• Common Device Name: FULLFIRE¿ DIFFUSING TIP LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 6887370
• Report Number: 3009970070-2017-00142
• Device Sequence Number: 636667
• Product Code: GEX
• UDI-Device Identifier: 00816589020465
• UDI-Public: 00816589020465
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/22/2017

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: 10/27/2017
• Device Catalogue Number: FFS002-01
• Device Lot Number: C6690-09
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/22/2017
• Supplement Date Received by Manufacturer: 09/22/2017; 09/26/2017; 04/30/2018; 06/06/2018
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 09/22/2017; 10/03/2017; 05/07/2018; 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR