DeRoyal 89-7577Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756740517), received between Oct 4, 2019 and Oct 4, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2019Material Separation; Material Integrity Problem; Material Separation; Material Integrity Problem

  THE 4-X4 GAUZE CONTAINED IN THE CONVENIENCE KIT WERE SEPARATING, CREATING THE OPPORTUNITY TO SEPARATE INSIDE THE BODY CAVITY WITH A POTENTIAL COUNT ERROR OR RETAINED GAUZE IN THE BODY CAVITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9155907 ↗