Dornier MedTech 600 Micron SU Thulio Performance 3m FiberRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810116023318), received between Sep 9, 2025 and May 20, 2026 — classified as 2 malfunctions.

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

• MalfunctionMay 20, 2026Break

  DMTA RECEIVED A REPORT THAT THE DISTAL TIP OF THE FIBER BROKE INSIDE A PATIENT'S KIDNEY DURING A PROCEDURE. THE FRAGMENT WAS RETRIEVED, AND NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230751 ↗
• MalfunctionSep 9, 2025No Apparent Adverse Event; No Apparent Adverse Event

  DMTA RECEIVED A MEDSUN REPORT, (B)(4), WHERE THE USER STATES THEY HEARD CRACKLING AND SAW SMOKE COMING FROM THE LASER FIBER AS IT WAS CONNECTED TO THE LASER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009542 ↗