DeRoyal 88-E0031Recalls & reported problems
Deroyal Industries, Inc. · Electrosurgical Pencil · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00749756803007), received between Dec 20, 2018 and Feb 12, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (3 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
Device problems
- Electrical /Electronic Property Problem3
- Circuit Failure2
- Electrical Shorting2
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2019Circuit Failure; Electrical /Electronic Property Problem; Electrical Shorting; Circuit Failure; Electrical /Electronic Property Problem; Electrical Shorting
THE PENCIL IS GETTING AN ELECTRIC SHORTAGE WHEN SOAKED WITH BLOOD OR SALINE. THE CAUTERY MACHINE EITHER SHOWS ERROR OR CONTINUOUSLY COAGULATING/CUTTING WITHOUT USING BUTTONS. THE END USER IS CONCERNED IT MAY LEAD TO ELECTRIC SHOCK OR SEVERE INJURY TO THE PATIENT OR STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8333444 ↗MalfunctionFeb 12, 2019Circuit Failure; Electrical /Electronic Property Problem; Electrical Shorting; Circuit Failure; Electrical /Electronic Property Problem; Electrical Shorting
THE PENCIL IS GETTING AN ELECTRIC SHORTAGE WHEN SOAKED WITH BLOOD OR SALINE. THE CAUTERY MACHINE EITHER SHOWS ERROR OR CONTINUOUSLY COAGULATING/CUTTING WITHOUT USING THE BUTTONS. THE END USER IS CONCERNED IT MAY LEAD TO ELECTRIC SHOCK OR SEVERE INJURY TO THE PATIENT OR STAFF.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8333438 ↗MalfunctionDec 20, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
THE CUT BUTTON ON THE ELECTROSURGICAL PENCIL WAS NOT WORKING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8185269 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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