NeuroBlate Optic FullFire® Laser Probe 20895-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589021028), received between Apr 4, 2019 and Apr 4, 2019 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2019Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE CLINICAL SPECIALIST (CS) PLUGGED IN THE LASER FIBER TO CHECK THE PILOT LIGHT ON THE LASER PROBE THERE WAS NO LIGHT EMITTING FROM THE PROBE TIP. THE CS PLUGGED THE PROBE IN MULTIPLE TIMES AND THERE WAS NO LIGHT EMITTING FROM EITHER THE UMBILICAL'S OR THE TIP OF THE PROBE. THE USER DID NOT USE THE PROBE AND IT WAS REPLACED WITH ANOTHER PROBE AND IT FUNCTIONED NORMALLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8484529 ↗