NA 4111127090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540216816), received between Sep 27, 2018 and Sep 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2018Packaging 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 DURING PREPARATION FOR A SURGICAL PROCEDURE. IT WAS FURTHER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT, NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7913886 ↗