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

Catalog Number	FFS002-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Monteris is submitting this report despite the malfunction being solely the result of use-error with no other performance issue.Mdr #: 3009970070-2018-00031 will be submitted for cold pixels.The malfunctions are not related and occurred at different times in the case, however, it was during the same case.Mdr# 3009970070-2018-00031 was submitted for cold pixels.The malfunctions are not related and occurred at different times during the ablation procedure.Mdr # 3009970070-2018-00031 occurred during the ablation procedure.This mdr number is being referenced as it occurred during the same case as mdr # 3009970070-2018-00037.
Event or Problem Description
Background: monteris medical issued a safety notification to all neuroblate users on october 5, 2017 in order to mitigate a risk of certain mri systems that have been shown to interact with the neuroblate probe and create unintended heating at the probe tip.Among other information the safety notification provided instruction to utilize certain mri scans that were shown to prevent the occurrence of the malfunction.It was reported in this case that a health care professional (hcp) performed an mri scan that was not consistent with information provided previously in the form of a safety advisory notice.As with all neuroblate procedures a monteris employee was in attendance at the procedure in a support role.During the neuroblate procedure, the monteris employee noticed anomalous data in the probe thermocouple reading as reported by m-vision software.The monteris employee then noticed the incorrect mri scan was being performed and instructed the hcp to stop the mri scan.The hcp then promptly stopped the mri scan.These events were reported to occur over the course of approximately 5 seconds.A 3d t1 mri scan was completed which showed no abnormalities, and the procedure proceeded normally.Another 3d t1 mri scan was completed following the treatment to determine the extent of ablation.The probe was removed and appeared normal upon gross inspection.There were no patient complications reported in relation to this event.The hcp who prescribed the incorrect mri scan type was retrained to the content in the safety advisory notice to prevent recurrence of this use error.
Additional Manufacturer Narrative
Additional device evaluation: the probe was tested and functioned as intended.

• 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: 7402925
• Report Number: 3009970070-2018-00037
• Device Sequence Number: 61625
• Product Code: GEX
• UDI-Device Identifier: 00816589020755
• UDI-Public: 00816589020755
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2018

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: 08/08/2019
• Device Catalogue Number: FFS002-01
• Device Lot Number: C8995-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1