NA 0277010240Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540050557), received between Aug 7, 2018 and Feb 19, 2021 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 19, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THERE WAS A POTENTIAL STERILITY BREACH ON THE PACKAGING OF THE DEVICE. IT WAS ALSO REPORTED THAT IT WAS NOTICED PRIOR TO A PROCEDURE AND NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11354191 ↗
• MalfunctionAug 7, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ORAL SURGICAL PROCEDURE, THE BUR BROKE AT THE CUTTING END. THE COMPLAINANT IS NOT AWARE OF ANY DELAYS OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7758999 ↗