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

Catalog Number	FFS522-01
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	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation of this event was performed.The probe that was removed from the patient was returned to monteris for analysis.The probe was found to be within defined specifications.In particular, there was no visible damage to the tip of the probe.Furthermore, monteris often analyses software logs from the neuroblate system to further assess complaints.The software log for this procedure was provided to monteris complaint handling for review.Analysis of the software log revealed a brief increase in temperature of the probe thermocouple reading from body temperature to 51.15c over approximately 4-5 seconds.The temperature reading then quickly returned to body temperature.Engineering analysis demonstrates this temperature rise was within acceptable performance specifications as it did not exceed the neuroblate thermal dose requirement.In addition, monteris has established criteria when reviewing neuroblate software logs from complaints to determine if the complaint indicates an mri induced rf heating of the probe.This criteria was previously provided to fda in december, 2017 ((b)(4)).The software log from this complaint was reviewed against these criteria and was found to not meet criteria that indicate an incident of mri induced rf heating of the probe.While the increase in probe temperature reading was well within engineering specifications and not indicative of a risk of injury to the patient this event occurred solely because a user did not follow instruction provided in a safety notification.Monteris is submitting this report despite the malfunction being solely the result of use-error with no other performance issue.
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.It was noted that the probe umbilicals were not contacting the mr bore.The probe was then removed from the patient.A t2 mri scan was completed which showed no abnormalities.The probe was replaced with a different probe and the procedure continued.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.

• 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: 7325987
• Report Number: 3009970070-2018-00027
• Device Sequence Number: 151212
• Product Code: GEX
• UDI-Device Identifier: 00816589020748
• UDI-Public: 00816589020748
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172881
• 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
• Report Date (Section B): 03/08/2018

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: 10/25/2019
• Device Catalogue Number: FFS522-01
• Device Lot Number: D0764-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1