NeuroBlate Optic SideFire® Laser Probe 20891-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816589020885), received between Jan 4, 2019 and Sep 30, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Radiation Leak; Radiation Leak

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT WHEN THE USER STARTED ABLATING, NO HEAT WAS OBSERVED. THE USER WALKED INTO THE MRI ROOM TO INSPECT THE LASER PROBE, AND IT WAS FOUND THAT THE PROBE'S LASER FIBER CABLE WAS THERMALLY DAMAGED. THE LASER WAS REMOVED AND REPLACED WITH A NEW ONE. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20337309 ↗
• MalfunctionApr 6, 2023Radiation Leak; Radiation Leak

  DURING A PROCEDURE, A PROBE WAS OPENED FROM ITS PACKAGING AND THE PILOT LASER LIGHT WAS CHECKED. THE LIGHT LOOKED VISIBLY DIM AT THE TIP. IT WAS THEN NOTICED THAT THERE WAS A LIGHT LEAK AROUND THE AREA OF THE DEPTH STOP ADJUSTMENT. IT WAS DECIDED THAT THE PROBE COULD NOT BE USED, AND A SECOND PROBE WAS OPENED AND USED WITHOUT ISSUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690493 ↗
• MalfunctionMar 10, 2023Radiation Leak; Radiation Leak

  UPON PLUGGING IN THE LASER PROBE TO TEST DURING THE PROCEDURE, EVERYTHING WAS NORMAL, WITH LASER LIGHT EMITTING FROM ONLY THE TIP OF THE LASER PROBE. WHEN THE PATIENT WAS POSITIONED TO ISOCENTER OF THE MRI, THE CLINICAL SPECIALIST NOTICED LASER LIGHT EMITTING FROM THE PROBE UMBILICALS. THE LASER PROBE WAS REMOVED AND REPLACED WITH A DIFFERENT LASER PROBE. THE DEFECTIVE LASER PROBE WAS DISPOSED OF AT THE SITE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521880 ↗
• MalfunctionNov 9, 2020Insufficient Heating; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, UPON FIRING THE LASER IT WAS NOTICED THERE WAS NO HEATING IN THE THERMAL MAP. AFTER SEVERAL MINUTES THE LINES WERE CHECKED AND IT WAS DISCOVERED THE LASER FIBER HAD A VOID TO THE PORTABLE CONNECTOR MODULE. A NEW PROBE WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10808607 ↗
• MalfunctionAug 29, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE FIRST LASER THAT WAS OPENED HAD A BREAK IN THE FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8946925 ↗
• MalfunctionJan 4, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING TESTING AT SUNY, A PROBE WAS OPENED AND IT WAS NOTED THAT THE LASER FIBER WAS BROKEN AND THE CLINICAL SPECIALIST COULD SEE THE PILOT LIGHT THROUGH THE WOVEN SHEATH. THERE WERE NO PATIENT COMPLICATIONS AS NO PATIENT WAS INVOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8218915 ↗