SideFire® Directional Laser Probe 20368-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589020779), received between Jul 2, 2018 and Jul 2, 2018 — classified as 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BACKGROUND: MONTERIS MEDICAL ISSUED A SAFETY NOTIFICATION TO ALL NEUROBLATE USERS ON (B)(6) 2017 IN ORDER TO MITIGATE A RISK OF CERTAIN MRI SYSTEMS THAT HAVE BEEN SHOWN TO INTERACT WITH THE NEUROBLATE PROBE AND CREATE UNINTENDED HEATING AT THE PROBE TIP. AMONG OTHER INFORMATION THE SAFETY NOTIFICATION PROVIDED INSTRUCTION TO UTILIZE CERTAIN MRI SCANS THAT WERE SHOWN TO PREVENT THE OCCURRENCE OF THE MALFUNCTION. IT WAS REPORTED IN THIS CASE THAT A HEALTH CARE PROFESSIONAL (HCP) PERFORMED AN MRI SCAN THAT WAS NOT CONSISTENT WITH INFORMATION PROVIDED PREVIOUSLY IN THE FORM OF A SAFETY ADVISORY NOTICE. AS WITH ALL NEUROBLATE PROCEDURES A MONTERIS EMPLOYEE WAS IN ATTENDANCE AT THE PROCEDURE IN A SUPPORT ROLE. DESPITE ADVISEMENT FROM THE MONTERIS MEDICAL EMPLOYEE SUPPORTING THE CASE THE TREATING HCP CHOOSE TO DEVIATE FROM THE INSTRUCTION PROVIDED IN PREVIOUS SAFETY ADVISORY NOTICES BY UTILIZING A T2 SCAN WITH THE PROBE IN THE PATIENT'S BRAIN. DURING THE T2 SCAN THE MONTERIS EMPLOYEE NOTICED ANOMALOUS DATA IN THE PROBE THERMOCOUPLE READING AS REPORTED BY M-VISION SOFTWARE. THE MONTERIS EMPLOYEE INSTRUCTED THE HCP TO STOP THE MRI SCAN. THE HCP THEN PROMPTLY STOPPED THE MRI SCAN. THESE EVEN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7654498 ↗