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

Model Number	20891-1
Medical Device Problem Codes	Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, the user noticed that there was damage to the probe fiber.It was noted that there was a pilot light seen on insertion but when the user went to administer therapy, three different times, no change in in pixel color (temperature) was noticed.All break points in the fiber line were checked for secure attachment and a dummy (un-sterile) probe was used to prove that we somehow had a faulty probe.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Additional information: d10, h6, h10.Device evaluation: the probe was returned and cleaned.The laser fiber break was confirmed at the base of the clamp shell.The fiber was also noted to be melted at the location which is expeected as the laser was fired.

• 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
• MDR Report Key: 10154942
• Report Number: 3009970070-2020-00046
• Device Sequence Number: 2163888
• Product Code: GEX
• UDI-Device Identifier: 00816589020953
• UDI-Public: 00816589020953
• Combination Product (Y/N): N
• 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): 06/15/2020

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: 02/26/2021
• Device Model Number: 20891-1
• Device Catalogue Number: NBP-101-01
• Device Lot Number: 124B9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1