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

Catalog Number	FFS522-01
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, the probe was placed and the thermocouple was not registering properly.It was noted that the probe was discarded and a second probe was placed.It was noted that the second thermocouple was measuring appropriately.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
Additional information: review of the complaint files determined this mdr should not have been reported.This mdr was reported in response to a medwatch received by monteris.The event did not cause a death or serious injury, nor would it if the event were to recur.

• Brand Name: FULLFIRE SELECT DIFFUSING TIP LASER PROBE
• Common Device Name: FULLFIRE¿ SELECT DIFFUSING TIP LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 6587324
• Report Number: 3009970070-2017-20221
• Device Sequence Number: 324192
• Product Code: GEX
• UDI-Device Identifier: 00816589020427
• UDI-Public: 00816589020427
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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: 07/31/2018
• Device Catalogue Number: FFS522-01
• Device Lot Number: C7193-09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR