NeuroBlate Optic SideFire® Laser Probe 20891-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816589020878), received between Jan 4, 2019 and Dec 9, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Radiation Leak” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Radiation Leak; Radiation Leak

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT WHILE ABLATING, HEAT WAS NO LONGER VISIBLE IN THE TREATMENT AREA DESPITE THE LASER BEING FIRED, AND THE TEMPERATURE READING AT THE HOTTEST POINT HAD DECREASED. THE PROBE WAS CHECKED AND IT WAS NOTICED THAT THE OUTER SHEATH OF THE CABLE WAS THERMALLY DAMAGED. THE PROBE WAS REPLACED AND THE TREATMENT RESUMED WITH NO FURTHER ISSUES. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20883276 ↗
• MalfunctionDec 6, 2023Radiation Leak; Radiation Leak

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT, PRIOR TO INSERTING THE PROBE THROUGH THE ROBOTIC PROBE DRIVER, THE COOLING AND PILOT LIGHT WERE CHECKED. NO ISSUES WERE NOTED AT THIS TIME. THE VOLUMETRIC MRI SCAN WAS RUN, COORDINATES WERE ENTERED, AND THE ABLATION STARTED. FOR THE FIRST MINUTE, THE ABLATION WENT AS PLANNED AND THE PROBE FUNCTIONED AS INTENDED. AFTER THE FIRST MINUTE PASSED, IT WAS NOTED THAT THE SIDEFIRE PROBE BEING USED WAS NOT OBSERVED TO BE HEATING THE TARGETTED LESION. SINCE THE STOPPING POINT HAS BEEN REACHED, A NEW BURN WAS STARTED AT THE SAME POINT. THE USER BEGAN ABLATING AGAIN AFTER STARTING THE MRI, WITH NO HEAT BEING NOTED ON THE NOISE MASK. THE ABLATION WAS PAUSED, AND UPON WALKING INTO THE MRI, THE PROBE WAS INSPECTED AND A RED PILOT LIGHT WAS VISIBLE HALFWAY UP THE PROBE WIRE. THE PROBE WAS REMOVED AND WAS SENT BACK TO THE MONTERIS HEADQUARTERS. A NEW PROBE WAS INSERTED, AND THE ABLATION CONTINUED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274399 ↗
• MalfunctionJan 4, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE RED LIGHT AT THE TIP WAS FAINT, AND THERE WAS VISIBLE LIGHT EXITING THROUGH THE UMBILICAL CLOSE TO THE DEPTH STOP. THIS WAS NOTED AFTER REMOVAL FROM THE PACKAGE, THE LASER FIBER WAS PLUGGED IN. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8218955 ↗