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

Catalog Number	DTP-000-01
Medical Device Problem Code	Charred (1086)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial device evaluation: the device history record (dhr) was reviewed and the probe met all specifications prior to shipping.Software log analysis was reviewed.The probe thermocouple readings presented normally.The returned probe was visually inspected using magnification; evidence of coagulum and charring was observed on the external surface of the lens.A white material was also observed on the outside of the lens.The lens was intact.The cooling line and thermocouple assemblies at the distal end were observed to be intact and normal based on visual inspection.The application of wax into the bolt likely resulted in it being transferred to the probe lens outside surface.The wax likely absorbed laser energy causing local heating at the lens external surface that resulted in coagulum and char.
Event or Problem Description
It was reported that after treatment when the probe was removed, the probe showed some signs of charring on the outside of the probe tip/window.This appeared to be charred tissue or material and the probe did not appear damaged internally.It was noted that the scrub tech placed bone wax on the bolt to hold the bolt to the driver prior to bolt placement.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Additional device evaluation: the returned probe was analyzed using ftir analysis.The material visually observed on in the external lens tip was found to be denatured tissue.As it was noted in the event description, the scrub technician placed bone wax on the bolt to hold the bolt to the driver prior to placement of the bolt.The application of wax into the bolt likely resulted in it being transferred to the probe lens outside surface.The wax likely absorbed laser energy causing local heating at the lens external surface that resulted in coagulum and char.

• 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: 7026905
• Report Number: 3009970070-2017-00166
• Device Sequence Number: 1770005
• Product Code: GEX
• UDI-Device Identifier: 00816589020823
• UDI-Public: 00816589020823
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081509
• 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): 11/13/2017

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: 01/30/2019
• Device Catalogue Number: DTP-000-01
• Device Lot Number: C9082-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 03/13/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1