DeRoyal 89-5309Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756632737), received between Jan 5, 2022 and Feb 7, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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.

• MalfunctionFeb 7, 2022Material Puncture/Hole; Device Damaged Prior to Use; Material Puncture/Hole; Device Damaged Prior to Use

  OUTER PLASTIC WRAP WAS INTACT; BACK TABLE COVER HAD A HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471240 ↗
• MalfunctionJan 5, 2022Tear, Rip or Hole in Device Packaging

  SURGICAL TECHNOLOGIST INSPECTED OUTER PLASTIC WRAP OF MINOR PACK AND IT WAS INTACT. UPON UNFOLDING THE BACK TABLE COVER THAT THE PACK IS WRAPPED IN, SHE DISCOVERED A HOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13168169 ↗