NeuroBlate Optic FullFire® Laser Probe 20895-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589021073), received between Jan 7, 2022 and Jan 7, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2022Radiation Leak; Melted; Radiation Leak; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT COOLING BEGAN AND CONFIRMED COOL PIXELS APPEARING IN THERMAL MASK. USER BEGAN FIRING THE LASER AT THE WORKSTATION, AND AFTER THE CLINICAL SPECIALIST SAW NO CHANGE IN THERMAL MASK AFTER SEVERAL MEASUREMENTS, THE CLINICAL SPECIALIST ASKED TO USER TO STOP FIRING. UPON INSPECTION OF LASER AT BACK OF BORE, AN ODOR OF SMOKE WAS IMMEDIATELY DETECTED, AND A CHARRED POINT ON THE LASER UMBILICALS WAS FOUND. LASER WAS REPLACED AND ABLATION RESUMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191300 ↗