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

Catalog Number	FFS122-01
Medical Device Problem Codes	Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, that when the clinical specialist (cs) checked the laser output of the probe, there was no red light output.Physician checked it before inserting it so no patient interference and then had a back up one, so no time was added to the case.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation: the probe laser connector was connected to test the system to observe the pilot light.No pilot light was visible; no light was visible through the umbilicals or jacket but a break location can be inferred from the deformation and curvature discontinuity of the fiber jacket.Due to no pilot light being visible, the break was significant enough to prevent leakage across the break surface.

• 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: 8199656
• Report Number: 3009970070-2018-00094
• Device Sequence Number: 1448671
• Product Code: GEX
• UDI-Device Identifier: 00816589021035
• UDI-Public: 00816589021035
• 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): 12/27/2018

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: 09/23/2019
• Device Catalogue Number: FFS122-01
• Device Lot Number: D1738-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1