NA 72201514Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010624932), received between Aug 15, 2023 and Apr 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Flaked” (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.

• MalfunctionApr 23, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THERE WERE METAL SHAVINGS OR FRAGMENTS NOTED WHILE USING THE INCISOR PLUS ELITE. ALL FRAGMENTS REMOVED BY SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME FAULTY DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169446 ↗
• MalfunctionAug 15, 2023Flaked; Flaked

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE INCISOR BLADE WAS ATTACHED TO A SHAVER HANDPIECE AND ROTATED, METAL POWDER OF THE BLADE FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552683 ↗