DeRoyal 89-10556Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756364287), received between Aug 2, 2021 and Aug 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AFTER PATIENT WAS ASLEEP FOR SURGICAL PROCEDURE, SUPPLY ON THE STERILE FIELD WAS CONTAMINATED FROM FACTORY. SUCTION TUBING CONTAMINATED WITH RED SUBSTANCE ON OUTSIDE OF TUBING. ALL STERILE SUPPLIES AND INSTRUMENTS ON THE FIELD HAD TO BE REPLACED. SUCTION TUBING SAVED FOR QUALITY. (CMC HYSTEROSCOPY PACK)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258390 ↗