Dornier MedTech 600 Micron Single UseRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810116020027), received between Oct 25, 2019 and Mar 8, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 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.

• MalfunctionMar 8, 2021Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  COMPLAINANT REPORTED A DISPOSABLE LASER FIBER WAS FOUND BROKEN IN THE PACKAGE. THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER (B)(4) ON 10/17/2019.

  Patient problems: Insufficient Information

  MAUDE report 11435088 ↗
• MalfunctionOct 25, 2019Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  COMPLAINANT REPORTED A DISPOSABLE LASER FIBER WAS FOUND BROKEN IN THE PACKAGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9238318 ↗