NA 2108109000S9Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613153090915), received between Apr 8, 2019 and Apr 8, 2019 — 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.

• MalfunctionApr 8, 2019Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THAT INNER PACK OF THE BLADE WAS SEALED WITH THE OUTER PACK AND BLADE WOULD NOT DROP DOWN INTO THE STERILE FIELD. IT WAS ALSO REPORTED THAT THERE WAS NO DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Patient Involvement

  MAUDE report 8491891 ↗