MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE OPTIC FULLFIRE® LASER PROBE

Catalog Number	DTP-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	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: the presence of a broken laser fiber was confirmed via visual inspection of the probe.The probe was disassembled around the area noted to be burned.The laser fiber was cracked upon inspection just proximally to the join where the umbilical and rail positioner meet.The area of the laser fiber break on the umbilical is an area of high stress as the rigid potted bond just distal to the fiber break does not allow the laser fiber to bend in response to loading.It was noted it is possible that the laser fiber could have been broken during use if bent at this location, but due to the damage caused by the laser energy it is impossible to determine if the laser fiber defect existed prior to its use by the physician.
Event or Problem Description
It was reported that during an ablation procedure, the probe might have cracked along the cabling during the patient transport.The user placed the probe in the operating room and then transported the patient with the probe inserted to the mri.It was also noted that the clinical specialist (cs) went in the room to check the laser probe and there was a visible burn on the probe cabling behind the yellow depth lock.The cs checked all of the laser fiber connections from the rack to the panel as well as the panel to the portable connector module (pcm) to make sure that the fiber connections were plugged in securely.All connected looked secure.The clinical specialist switched out the probe and continued the case successfully.There were no patient complications reported in relation to this event.

• Brand Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Common Device Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 8533058
• Report Number: 3009970070-2019-00031
• Device Sequence Number: 19158399
• Product Code: GEX
• UDI-Device Identifier: 00816589020953
• UDI-Public: 00816589020953
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K182036
• 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): 04/19/2019

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: 12/18/2020
• Device Catalogue Number: DTP-000-01
• Device Lot Number: D1761-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1