DeRoyal 89-10552Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00749756363549), received between Aug 2, 2021 and Aug 7, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (11 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. Apr 17, 2023Open, Classified

   The custom procedure packs contain light handle covers that have been recalled by another firm.

   Z-1691-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  OPENED UP A CMC EXTREMITY PACK. WHEN WE WERE UNPACKING THE PACK, WE FOUND A HAIR IN THE WEAVE OF THE BOTTOM SHEET. EVERYTHING WAS TAKEN DOWN AND NEW PACK WAS DONE. THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19928477 ↗
• MalfunctionJan 31, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PACK WAS FOUND TO HAVE A LONG DARK COLORED HAIR IN THE INNER WRAPPED BLUE BASIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614116 ↗
• MalfunctionDec 12, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  SUBSTANCE FOUND ON RAYTEC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18309773 ↗
• MalfunctionNov 13, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR ON BACK TABLE COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119517 ↗
• MalfunctionFeb 7, 2023Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem

  SPONGES FROM PACK HAVE THE THREADS COMING OUT OF SPONGES, NOTE AFTER INCISION, SPONGES REMOVED FROM FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311744 ↗
• MalfunctionFeb 7, 2023Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem

  XRAY SPONGES HAD THREAD COMING OUT OF THE SPONGES. THEY WERE FALLING APART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311729 ↗
• MalfunctionFeb 1, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  LONG HAIR WRAPPED IN THE SUCTION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277760 ↗
• MalfunctionJan 11, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR IN BLUE BASIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16136714 ↗
• MalfunctionDec 28, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR FOUND IN THE BIG BLUE BASIN OF THE EXTREMITY PACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16059733 ↗
• MalfunctionDec 27, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  HAIR IN BASIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052924 ↗
• MalfunctionNov 21, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  WE OPENED A STERILE BACK TABLE COVER. IT WAS A CMC EXTREMITY PACK AND WE SET UP THE TABLE AND WHEN WE POURED THE SALINE INTO THE CONTAINER, THERE WAS A HAIR IN CONTAINER. WE TORE DOWN THE ENTIRE BACK TABLE AND REPLACED IT WITH NEW ITEMS. THE PATIENT WAS NEVER IN THE ROOM. NEW EQUIPMENT WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837435 ↗
• MalfunctionMar 3, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CONTAMINANT INSIDE LID OF SPECIMEN CONTAINER. FOUND BEFORE PATIENT ENTERED THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13660013 ↗
• MalfunctionDec 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CAUTERY PENCIL IN THE (CMC EXTREMITY PACK) REPORTED TO HAVE BURNED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13088239 ↗
• MalfunctionAug 2, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CONTAMINATED PACKS FOR CASE. THE FIRST EXTREMITY PACK WE FOUND SMALL BLACK PIECES ON THE MEDICINE CUP. THIS WAS BEFORE THE PATIENT ENTERED THE ROOM. THE PACK WAS BROKEN DOWN AND THE ENTIRE SETUP WAS RESET. FOR THE SAME CASE, THE PATIENT WAS ASLEEP AND POSITIONED. THE 2ND EXTREMITY PACK WAS IN USE WHEN THE SCRUB TECH NOTICED BLACK PIECES ON MEDICINE CUP AND WHAT APPEARED TO BE DRIED BLOOD/RED SUBSTANCE ON THE SUCTION TUBING WHILE HANDING THE SUCTION TO THE SURGEON. THE TEAM LEADER WAS CALLED INTO THE ROOM. IT WAS DECIDED TO QUICKLY REMOVE CONTAMINATED SETUP AND RESET THE CASE. BOTH PACKS WERE THE (CMC EXTREMITY PACKS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258395 ↗