FullFire® Diffusing Tip Laser Probe 20414-00 (REF DTP-001-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816589020601), received between Sep 12, 2017 and Oct 3, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionOct 3, 2017Temperature Problem; Temperature Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT IS DECEASED BUT THE DEATH IS NOT ATTRIBUTED TO NEUROBLATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6912403 ↗
• MalfunctionSep 12, 2017Bent; Charred; Device Operates Differently Than Expected; Bent; Charred; Device Operates Differently Than Expected

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, AFTER FINISHING THE CASE, THE USER WENT TO PULL OUT THE PROBE OF THE ROBOTIC PROBE DRIVER (RPD) AND BOLT. IT WAS NOTED THAT IT WAS VERY DIFFICULT TO PULL OUT. ONCE THE PROBE WAS OUT, IT WAS NOTICED THAT IT "DIDN'T LOOK RIGHT" AND THAT THE PROBE HAD A SLIGHT BEND IN IT AND THAT IT WAS DARKER AROUND THE TIP. 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 6859596 ↗