FullFire® Select Diffusing Tip Laser Probe 20624-4 (REF FFS422-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816589020502), received between Sep 29, 2017 and Sep 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Temperature Problem” (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 16, 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 29, 2017Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THERE WAS UNINTENDED PROBE HEATING. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6903333 ↗