DeRoyal 89-2575Recalls & reported problems
Deroyal Industries, Inc. · PLASTIC PROCEDURE · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756281379), received between Oct 15, 2020 and Oct 15, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Continuous Firing” (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
Device problems
- Continuous Firing1
- Electrical /Electronic Property Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2020Continuous Firing; Electrical /Electronic Property Problem; Continuous Firing; Electrical /Electronic Property Problem
THE CAUTERY PENCIL WAS PLUGGED INTO AN FT10 UNIT. THE SURGEON ACTIVATED THE PENCIL, AND RELEASED THE BUTTON. AFTER RELEASING THE BUTTON, THE PENCIL CONTINUED TO OPERATE. THE PENCIL CONTINUED TO MALFUNCTION AFTER BEING SWITCHED FROM MONOPOLAR 1 TO MONOPOLAR 2. EVENTUALLY, IT WAS SWITCHED OUT WITH A DIFFERENT PRODUCT. THE CAUTERY PENCIL WAS PACKAGED IN A CONVENIENCE KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10684756 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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