NeuroBlate Optic FullFire® Laser Probe 20895-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589021011), received between Sep 23, 2022 and Sep 23, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.

• MalfunctionSep 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE LASER PILOT LIGHT WAS VISIBLE FROM THE BASE OF THE DEPTH STOP AND LOCKING INTERFACE PRIOR TO INSERTING THE PROBE INTO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15471453 ↗