DeRoyal 89-9810Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756945448), received between Jan 9, 2019 and Mar 28, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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.

• MalfunctionMar 28, 2019Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem

  THERE WAS A LARGE HOLE IN A LIGHT HANDLE COVER THAT WAS NOT DISCOVERED UNTIL AFTER THE PROCEDURE WAS COMPLETED, THUS CONTAMINATING THE STERILE FIELD. THE LIGHT HANDLE COVER WAS PACKAGED IN A CONVENIENCE KIT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8460067 ↗
• MalfunctionJan 9, 2019Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem

  A CONVENIENCE KIT CONTAINED A LIGHT HANDLE COVER THAT HAD A HOLE. THE DEVICE WAS BEING USED IN A PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8231047 ↗