MAUDE Adverse Event Report: MONTERIS MEDICAL SIDEFIRE DIRECTIONAL LASER PROBE; SIDEFIRE¿ DIRECTIONAL LASER PROBE

Catalog Number	NBP-000-01
Medical Device Problem Codes	Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, the laser fiber of the probe burned above the portable connector module (pcm) connection.Upon starting the laser ablation, the heat was increasing at a slow rate on the noise mask.The user then stopped lasing and the clinical specialist (cs) went into the magnet bay and immediately smelled burning plastic.It was noted that above the laser fiber plug, the fiber was charred.The probe was then disconnected and a new probe was inserted.The user was able to continue with the ablation without issue.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation: the device was inspected and it was noted that the damaged laser fiber was within the strain relief near the connector.The fiber insulation and strain relief were melted and burned.
Event or Problem Description
It was reported that during an ablation procedure, upon starting the laser ablation, the heat was increasing at a slow rate on the noise mask.The user then stopped lasing and the clinical specialist (cs) went into the magnet bay and detected an abnormal smell.It was noted that above the laser fiber plug, the fiber was discolored and had a void.The probe was then disconnected and a new probe was inserted.The user was able to continue with the ablation without issue.There were no patient complications reported in relation to this event.

• Brand Name: SIDEFIRE DIRECTIONAL LASER PROBE
• Common Device Name: SIDEFIRE¿ DIRECTIONAL LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 8001619
• Report Number: 3009970070-2018-00077
• Device Sequence Number: 16420178
• Product Code: GEX
• UDI-Device Identifier: 00816589020816
• UDI-Public: 00816589020816
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131278
• 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): 10/24/2018

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: 05/29/2020
• Device Catalogue Number: NBP-000-01
• Device Lot Number: 41041-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1