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

Catalog Number	DTP-001-01
Medical Device Problem Codes	Bent (1059); Charred (1086); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the device was returned and had black artifact and damaged peek material at the distal end.
Event or Problem Description
It was reported that following an ablation procedure, after finishing the case, the user went to pull out the probe of the robotic probe driver (rpd) and bolt.It was noted that it was very difficult to pull out.Once the probe was out, it was noticed that it "didn't look right" and that the probe had a slight bend in it and that it was darker around the tip.There were no patient complications reported in relation to this event.If additional information is received, a follow up report will be submitted.

• 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: 6859596
• Report Number: 3009970070-2017-00132
• Device Sequence Number: 16429573
• Product Code: GEX
• UDI-Device Identifier: 00816589020601
• UDI-Public: 00816589020601
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131278
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2019
• Device Catalogue Number: DTP-001-01
• Device Lot Number: C8092-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1