Elite DK-300 (REF DK300)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810633021958), received between Jun 30, 2021 and Mar 18, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STAPLE CAME OUT OF THE BOX DISENGAGED FROM INSERTION HANDLE. SURGEON DECIDED TO USE A PLATE INSTEAD. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF UNKNOWN LENGTH.

  Patient problems: Insufficient Information

  MAUDE report 21631146 ↗
• MalfunctionJun 30, 2021Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, WHILE THE DRILL KIT WAS OPENED FOR THE ELITE STAPLE. THE DRILL THAT WAS PROVIDED IN THE STERILE KIT WAS THE INCORRECT SIZE. A NEW DRILL KIT WAS OPENED. THERE WAS NO DELAY IN THE CASE. THE CASE WAS COMPLETED AS PLANNED. THIS REPORT IS FOR ONE (1) BME ELITE INSTRUMENT KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12091521 ↗