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

Model Number	20891-00
Medical Device Problem Codes	Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the probe was cleaned and the umbilical and pilot light imaged by connecting the probe to the test system to observe the pilot light.Approximately 90mm from the distal end of the probe umbilical red light could be seen emanating from within the probe umbilical.The presence of red light within the umbilical indicates a break in the laser fiber.The distal end of the probe was imaged with the pilot light connected and it was observed that when compared to a sidefire probe connected to the same system without a pilot light the amount of red light that exits the distal tip of the probe is reduced.Following imaging of the intact probe the probe umbilical was dissected.The result of the dissection confirmed a broken laser fiber and indicated that the break was contained within the clear protection tubing and that there was a viscous substance present on the laser fiber.
Event or Problem Description
It was reported that during an ablation procedure, the red light at the tip was faint, and there was visible light exiting through the umbilical close to the depth stop.This was noted after removal from the package, the laser fiber was plugged in.There were no patient complications reported in relation to this event.

• Brand Name: NEUROBLATE OPTIC SIDEFIRE® LASER PROBE
• Common Device Name: NEUROBLATE OPTIC SIDEFIRE® LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 8218955
• Report Number: 3009970070-2019-00002
• Device Sequence Number: 1657170
• Product Code: GEX
• UDI-Device Identifier: 00816589020878
• UDI-Public: 00816589020878
• 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,Followup
• Report Date (Section B): 01/04/2019

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: 09/23/2020
• Device Model Number: 20891-00
• Device Catalogue Number: NBP-001-01
• Device Lot Number: 07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1