DeRoyal 89-10563Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756363983), received between Aug 2, 2021 and Feb 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 30, 2023Open, Classified

   The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

   Z-2086-2023 · Root cause: Process control · FDA record ↗

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 8, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR FOUND IN ANTERIOR HIP PACK PGYBK 89-10563.03 BEFORE CASE WAS STARTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13483413 ↗
• MalfunctionAug 2, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SMALL HAIR FOUND IN BLUE SMALL BASIN FROM INSIDE DEROYAL SURGICAL SUPPLY PACK. FIELD CONTAMINATED. BLUE BASIN AND EVERYTHING INSIDE WAS THROWN OUT AND REPLACED. IRRISEPT AND LG OF VANC TO SURGICAL WOUND PER PHYSICIAN. IV RUN FOR 24 HRS. (ANTERIOR HIP PACK PGYBK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258402 ↗