NeuroBlate Optic FullFire® Laser Probe 20893-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816589020960), received between Jul 23, 2020 and Mar 29, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionMar 29, 2023Melted; Melted

  DURING A TWO TRAJECTORY ABLATION PROCEDURE, IT WAS REPORTED THAT THE TEMPERATURE CHANGE WAS TAPERING OFF, THEN NOT CHANGING. THE CLINICAL SPECIALIST WENT IN TO INVESTIGATE AND SAW THAT THE PCM LASER CONNECTION HAD BURNT THROUGH. A SPARE LASER WAS THEN CONNECTED TO COMPLETE CASE WITH NO FURTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637938 ↗
• MalfunctionJul 23, 2020Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING THE SETUP PRIOR TO AN ABLATION PROCEDURE, THE USER CHECKED THE PILOT LIGHT PRIOR TO INSERTING THE PROBE AND NOTED THAT THERE WAS NO PILOT LIGHT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10314734 ↗