MAUDE Adverse Event Report: MONTERIS MEDICAL FULLFIRE SELECT DIFFUSING TIP LASER PROBE; FULLFIRE¿ SELECT DIFFUSING TIP 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	09/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ablation procedure, the probe did not have heat output.The clinical specialist (cs) checked the laser output for the probe before inserting into the bolt and noticed the red beam.However, when firing the laser the user experienced cold pixels and no heating.The physician then removed the probe and there was no red beam anymore.This caused an approximate delay of 10 minutes.The user then switched out probes.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
The probe was visually inspected and noted a blackened hole through the umbilical sheath approximately 5 inches from the probe holder.The fiber was separated.The damaged created by firing the laser prevented analysis of the break location.The cooling line was also noted to have a pinhole near the site of the burn.

• 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: 8001511
• Report Number: 3009970070-2018-00080
• Device Sequence Number: 1773987
• 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,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: FFS122-01
• Device Lot Number: D1066-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1