DeRoyal 88-000015CRecalls & reported problems
Deroyal Industries, Inc. · Coated Blade Electrode · Class 2
Data updated Oct 16, 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 00749756338226), received between May 14, 2018 and May 14, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Product Quality 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
Device problems
- Product Quality Problem1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2018Product Quality Problem; Product Quality Problem
ACCORDING TO THE ROOM STAFF, THE PROBLEM WITH THE CAUTERY TIP (SPECIFICALLY DEROYAL 4" TIP #(B)(4)) WAS THAT AFTER CAUTERIZATION OF TISSUE, WHEN TAKING PENCIL TIP OFF OF TISSUE, THE ESCHAR REMAINED STUCK TO THE CAUTERY PENCIL AND "TORE" AWAY FROM THE CAUTERIZED TISSUE RATHER THAN REMAINING ON THE TISSUE, THUS CREATING MORE BLEEDING.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7512234 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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