Dornier MedTech Slim 270 Micron Single UseRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810116020348), received between Oct 4, 2019 and Jul 9, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2021No Apparent Adverse Event; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING 2 HOLMIUM FIBER UNITS WHICH WERE REPORTED TO HAVE CRACKS OUT OF PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144586 ↗
• MalfunctionMar 8, 2021No Apparent Adverse Event; No Apparent Adverse Event

  REPORT WAS RECEIVED (B)(6) 2019 DEALING A LASER FIBER BREAKAGE IDENTIFIED AT (B)(6) CENTER IN (B)(6). THIS COMPLAINT WAS INITIALLY REPORTED TO FDA UNDER (B)(4) ON (B)(6) 2019.

  Patient problems: Insufficient Information

  MAUDE report 11434198 ↗
• MalfunctionSep 9, 2020No Apparent Adverse Event; No Apparent Adverse Event

  A NOTIFICATION WAS RECEIVED REGARDING A HOLMIUM FIBER WHICH WAS REPORTED TO HAVE BURNED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10509939 ↗
• MalfunctionNov 4, 2019Fracture; No Apparent Adverse Event; Fracture; No Apparent Adverse Event

  COMPLAINANT REPORTED A LASER FIBER BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9274068 ↗
• MalfunctionOct 4, 2019No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER COMPLAINED A HOLMIUM FIBER BROKE WITHIN THE CHANNEL OF THE URETEROSCOPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9158348 ↗