MAUDE Adverse Event Report: Monteris Medical NeuroBlate® System

Model Number	20980
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction

• Brand Name: NeuroBlate® System
• Common Device Name: NeuroBlate® System
• Manufacturer (Section D): Monteris Medical; 131 cheshire ln; suite 100; minnetonka MN 55305
• Manufacturer Contact: michelle bergstrom ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 50874209
• Report Number: 3009970070-2026-00007
• Device Sequence Number: 9380392
• Product Code: GEX
• UDI-Device Identifier: 00816589021080
• UDI-Public: 00816589021080
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K193375
• 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
• Report Date (Section B): 09/23/2026

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 Model Number: 20980
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown