FullFire® Select Diffusing Tip Laser Probe 20624-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816589020427), received between May 24, 2017 and Sep 22, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  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 6887399 ↗
• MalfunctionMay 24, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE PROBE WAS PLACED AND THE THERMOCOUPLE WAS NOT REGISTERING PROPERLY. IT WAS NOTED THAT THE PROBE WAS DISCARDED AND A SECOND PROBE WAS PLACED. IT WAS NOTED THAT THE SECOND THERMOCOUPLE WAS MEASURING APPROPRIATELY. 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 6587324 ↗