NeuroBlate Optic FullFire® Laser Probe 20893-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816589020946), received between Nov 9, 2020 and Jan 28, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2022Radiation Leak; Radiation Leak

  IT WAS REPORTED THAT THE LASER FIBER PILOT LIGHT WAS LOW PRIOR TO THE START OF THE ABLATION PROCEDURE. NO VISIBLE BREAKS OR STRUCTURAL DAMAGE TO THE FIBER WERE NOTICED AT THE TIME OF THE EVENT. ADDITIONALLY, NO VISUAL LEAKAGE OF PILOT LIGHT ONTO UMBILICAL WAS OBSERVED AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13384681 ↗
• MalfunctionNov 9, 2020Material Puncture/Hole; Output Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, USER STEPPED ON PEDAL TO FIRE LASER, BUT NO HEAT PIXELS OR TDT LINES APPEARED. THE LASER FIBER HAD A VOID IN THE LASER FIBER CABLE CLOSE TO WHITE CONNECTION ON PROBE. THE LASER FIBER WAS REPLACED LASER AND THE CASE PROCEEDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10808642 ↗