DeRoyal 88-000702Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756157858), received between Jul 19, 2019 and Dec 10, 2019 — classified as 3 malfunctions.

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

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2019Mechanical Problem; Device Remains Activated; Failure to Shut Off; Physical Resistance/Sticking; Mechanical Problem; Device Remains Activated; Failure to Shut Off; Physical Resistance/Sticking

  THE CAUTERIZATION BUTTON GOT STUCK IN THE "ON" POSITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9445851 ↗
• MalfunctionOct 25, 2019Mechanical Problem; Mechanical Problem

  DURING USE, THE CAUTERY BUTTON IS STICKING IN THE "ON" POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9238779 ↗
• MalfunctionJul 19, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CAUTERY PENCIL BURNED A HOLE THROUGH THE HOLSTER. THE PENCIL ALSO HAS BURNED HOLES IN DRAPES AND TOWELS ON SEVERAL OCCASIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8806964 ↗