DeRoyal 88-E0032Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756803014), received between May 13, 2021 and May 13, 2021 — classified as 1 malfunction.

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

• MalfunctionMay 13, 2021Electrical /Electronic Property Problem; Compatibility Problem; Electrical /Electronic Property Problem; Compatibility Problem

  DURING AN OPERATION, A BURN MARK APPEARED ON THE SKIN OF A PATIENT AT THE PUNCTURE SITE OF THE DIATHERMY PEN, WHERE WE ALWAYS USE THE EZ-BLADES. THE BLADE WAS PROPERLY ATTACHED TO THE PIN. THERE WERE SCORCH MARKS ON THE DIATHERMY PEN OPENING.

  Patient problems: Rash; Skin Inflammation/ Irritation; Superficial (First Degree) Burn

  MAUDE report 11821141 ↗