MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20985
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2023 by the physician that the patient had a bleed post-operation on the same day of the litt procedure.The bleed was coded as urgent as it was classified as a hematoma.The physician was uncertain on how the bleed occured, however, they speculated that it may potentially be caused by the biopsy performed prior to the litt procedure.As a result, the physician performed surgery on the patient to remove the tissue around the ablation and the patient was treated post operatively afterwards.
Additional Manufacturer Narrative
Bleeding 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: dan hoseck ; 131 cheshire ln; suite 100; minnetonka, MN 55305
• MDR Report Key: 16513540
• Report Number: 3009970070-2023-00003
• Device Sequence Number: 20393209
• Product Code: GEX
• UDI-Device Identifier: 00816589021097
• UDI-Public: 00816589021097
• 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): 03/09/2023

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: 20985
• Device Catalogue Number: NB102-R
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/09/2020
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown