MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE OPTIC FULLFIRE® LASER PROBE

Catalog Number	FFS000-01
Medical Device Problem Codes	Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the probe was cleaned and no abnormalities were noted.A pilot light check was conducted and no pilot light was visible either through the umbilical or from the tip of the probe.The room lights were turned off and the probe was re-inspected, again with no light visible.The probe was then disassembled.The break was indicated by a kink in the fiber line at 40cm from the probe holder.The laser jacketing at the kink site was intact such that no light could escape.The undamaged condition of the breakout jacket confirmed that the probe was not fired.
Event or Problem Description
It was reported that during an ablation procedure, the clinical specialist (cs) plugged in the laser fiber to check the pilot light on the laser probe there was no light emitting from the probe tip.The cs plugged the probe in multiple times and there was no light emitting from either the umbilical's or the tip of the probe.The user did not use the probe and it was replaced with another probe and it functioned normally.There were no patient complications reported in relation to this event.

• Brand Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Common Device Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 8484529
• Report Number: 3009970070-2019-00026
• Device Sequence Number: 1538101
• Product Code: GEX
• UDI-Device Identifier: 00816589021028
• UDI-Public: 00816589021028
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182036
• 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): 04/04/2019

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: 09/19/2020
• Device Catalogue Number: FFS000-01
• Device Lot Number: D1733-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1