DeRoyal 89-9584Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756915281), received between Jan 15, 2020 and Jan 8, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  THE SKIN HOOK TIP BROKE OFF DURING USE. TIP HAD TO BE FISHED OUT OF INCISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464112 ↗
• MalfunctionMar 16, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  THE SKIN HOOK BROKE OFF AND HAD TO BE REMOVED FROM THE SURGICAL SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553554 ↗
• MalfunctionJan 15, 2020Break; Material Integrity Problem; Break; Material Integrity Problem

  A SKIN HOOK PACKAGED IN A CONVENIENCE KIT BROKE WHILE BEING USED IN AN EXCISION. THE TIP WAS EXTRICATED TO PREVENT A FOREIGN BODY BEING LEFT IN THE SURGICAL SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9590484 ↗