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

Model Number	20893-000
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Infection 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.
Event or Problem Description
The physician reported that the patient experienced an infection approximately 29 days post litt procedure.Per laantern registry information, a biopsy was performed the same day as litt procedure.According to a laantern registry ae form entered on (b)(6) 2023, the patient was "transferred from outside hospital facility complaint of dizziness, slurred speech, memory loss, and unsteady gait for 2 days.Also endorsed incision site pain and swelling" on (b)(6) 2023.Interventions included hospitalization starting on (b)(6) 2023 (discharge date not reported), surgical intervention of left sided cranial wound washout and mesh cranioplasty, picc line placement, and antibiotic therapy (per provided source documentation).Per the (b)(6) 2023 wound washout and mesh cranioplasty operative note findings, "frank purulence in subgaleal space and intradural space" was noted.

• Brand Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• Common Device Name: NEUROBLATE OPTIC FULLFIRE® LASER PROBE
• 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: 17993396
• Report Number: 3009970070-2023-00027
• Device Sequence Number: 20364197
• Product Code: GEX
• UDI-Device Identifier: 00816589020953
• UDI-Public: 00816589020953
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/23/2023

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 Expiration Date: 04/21/2024
• Device Model Number: 20893-000
• Device Catalogue Number: DTP-000-01
• Device Lot Number: 12162
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: A BIOPSY WAS DONE ON THE SAME DAY AS THE PROCEDURE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown