MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20980
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cerebral Edema (4403)
Date of Event	05/27/2026
Type of Reportable Event	Death
Event or Problem Description
The physician let monteris know that their patient from the ucd-135 case on (b)(6) 2026 had recently passed.After the litt procedure on that date, patient imaging showed significant edema.The physician performed a craniotomy that evening or the next day to relieve pressure from the edema.The physician commented that the whole brain showed significant edema and not just on the site of litt surgery, and the patient passed shortly after the craniotomy.Exact date of death is unknown to monteris.
Additional Manufacturer Narrative
Edema is a documented perioperative risk for brain surgeries such as mri-guided neurosurgical ablation.This documentation is available in the neuroblate ifu and in monteris' internal risk management files.No malfunction was alleged, therefore, no device evaluation was performed.

• 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: 25599734
• Report Number: 3009970070-2026-00005
• Device Sequence Number: 9802027
• 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): 06/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 20980
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2020
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown