NA 72201181Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010594457), received between May 23, 2019 and Mar 27, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY USING THE ELITE PREMIUM COMBINATION GRASPER, WHEN THE GRASPER WAS USED TO GRASP SOFT TISSUE IN THE JOINT, IT'S JAW SNAPPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580053 ↗
• MalfunctionMay 23, 2019Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE DEVICE BROKE AT THE PIN AXIS, AND ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635693 ↗