MAUDE Adverse Event Report: MONTERIS MEDICAL FULLFIRE SELECT DIFFUSING TIP LASER PROBE; FULLFIRE¿ SELECT DIFFUSING TIP LASER PROBE

Catalog Number	FFS222-01
Medical Device Problem Codes	Fracture (1260); Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: confirmation that the pilot light was not working by plugging the probe into the test system.The pilot light did not pass through the probe indicating a broken fiber.
Event or Problem Description
It was reported that during an ablation procedure, the user pulled the probe out of the packaging and set to the correct depth.The user then plugged in the e2k connector fully to check the pilot light and it was noted that there was no pilot light present.The user then switched probes out.There were no patient complications reported in relation to this event.

• Brand Name: FULLFIRE SELECT DIFFUSING TIP LASER PROBE
• Common Device Name: FULLFIRE¿ SELECT DIFFUSING TIP LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 8005198
• Report Number: 3009970070-2018-00083
• Device Sequence Number: 1531333
• Product Code: GEX
• UDI-Device Identifier: 00816589020700
• UDI-Public: 00816589020700
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K081509
• 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): 10/25/2018

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: 12/05/2018
• Device Catalogue Number: FFS222-01
• Device Lot Number: C9349-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1