MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20893-1
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The neuroblate system insturctions for use contain laser safety warnings as risk mitigations for this event: general warnings: "laser eye protection provided with the neuroblate system must be worn in the mri scanner room during operation of the laser" laser safety warnings: "ensure the laser fiber connections are made correctly.Improper connections may lead to equipment damage or operator injury." inspection, cleaning, disinfection, sterilization: "prior to use: carefully inspect all system laser cable/umbilical connections to ensure they have all completed the "two-click" connection, i.E., plug is pushed into mating connector so that one click at partial (half) insertion and a second click at full insertion." no harm was observed in this event, and the event description provided by the clinical specialist indicates that these instructions for risk mitigation were followed.Therefore, these risk mitigations remain effective.
Event or Problem Description
During a two trajectory ablation procedure, it was reported that the temperature change was tapering off, then not changing.The clinical specialist went in to investigate and saw that the pcm laser connection had burnt through.A spare laser was then connected to complete case with no further issues.There were no patient complications reported in relation to this event.
Event or Problem Description
During a two trajectory ablation procedure, it was reported that the temperature change was tapering off, then not changing.The clinical specialist went in to investigate and saw that the pcm laser connection had burnt through.A spare laser was then connected to complete case with no further issues.There were no patient complications reported in relation to this event.
Additional Manufacturer Narrative
The neuroblate system insturctions for use contain laser safety warnings as risk mitigations for this event: section 4.3, general warnings: "laser eye protection provided with the neuroblate system must be worn in the mri scanner room during operation of the laser" section 4.6, laser safety warnings: -"ensure the laser fiber connections are made correctly.Improper connections may lead to equipment damage or operator injury." section 4.7, inspection, cleaning, disinfection, sterilization: "prior to use: carefully inspect all system laser cable/umbilical connections to ensure they have all completed the "two-click" connection, i.E., plug is pushed into mating connector so that one click at partial (half) insertion and a second click at full insertion." no harm was observed in this event, and the event description provided by the clinical specialist indicates that these instructions for risk mitigation were followed.Therefore, these risk mitigations remain effective.The device was returned, examined, and was confirmed that the laser fiber had burnt through the connector and the housings of the portable connector module (pcm).Production records show that the device was assembled and functionally tested per required specifications.Historical data analysis shows that this failure has previously been attributed to incomplete connections at the mating adapter.A replacement pcm was sent back to the site per a service order that was completed on (b)(6) 2023.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: austin irwin ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 16637938
• Report Number: 3009970070-2023-00011
• Device Sequence Number: 6445822
• Product Code: GEX
• UDI-Device Identifier: 00816589020960
• UDI-Public: 00816589020960
• 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
• Serviced by Third Party (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): 06/13/2023

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: 07/28/2023
• Device Model Number: 20893-1
• Device Catalogue Number: DTP-101-01
• Device Lot Number: 11336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown