FullFire® Select Diffusing Tip Laser Probe 20624-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816589020700), received between Oct 24, 2018 and Oct 25, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2018Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT A PROBE WAS OPENED DURING AN ABLATION PROCEDURE AND CONTAINED A BROKEN FIBER. THE PROBE WAS INSERTED AND FIRED, HOWEVER NO HEATING WAS OBSERVED. THE PROBE WAS THEN REMOVED AND NO PILOT LIGHT WAS VISIBLE AT THE PROBE TIP. THE PROBE WAS REPLACED AND THE CASE PROCEEDED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005201 ↗
• MalfunctionOct 25, 2018Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE USER PULLED THE PROBE OUT OF THE PACKAGING AND SET TO THE CORRECT DEPTH. THE USER THEN PLUGGED IN THE E2K CONNECTOR FULLY TO CHECK THE PILOT LIGHT AND IT WAS NOTED THAT THERE WAS NO PILOT LIGHT PRESENT. THE USER THEN SWITCHED PROBES OUT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8005198 ↗
• MalfunctionOct 24, 2018Fracture; Insufficient Heating; Fracture; Insufficient Heating

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE PROBE DID NOT HAVE HEAT OUTPUT. THE CLINICAL SPECIALIST (CS) CHECKED THE LASER OUTPUT FOR THE PROBE BEFORE INSERTING INTO THE BOLT AND NOTICED THE RED BEAM. HOWEVER, WHEN FIRING THE LASER THE USER EXPERIENCED COLD PIXELS AND NO HEATING. THE PHYSICIAN THEN REMOVED THE PROBE AND THERE WAS NO RED BEAM ANYMORE. THIS CAUSED AN APPROXIMATE DELAY OF 10 MINUTES. THE USER THEN SWITCHED OUT PROBES. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8001511 ↗