DeRoyal 88-000M13CRecalls & reported problems
Deroyal Industries, Inc. · Coated Blade Electrode · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756136013), received between May 16, 2019 and Aug 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component or Accessory Incompatibility” (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.
Reports received per month
Most reported problems
Device problems
- Component or Accessory Incompatibility1
- Material Deformation1
- Material Integrity Problem1
- Material Protrusion/Extrusion1
- Melted1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2024Component or Accessory Incompatibility; Material Protrusion/Extrusion; Component or Accessory Incompatibility; Material Protrusion/Extrusion
A USER FACILITY REPORTED, "THE FIT OF THE TIP TO OUR CAUTERY HANDPIECE IS NOT SECURED. MOREOVER, THE INSULATION BALLOONS UP DURING THE PROCEDURE WHICH IS UNSAFE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19950643 ↗MalfunctionMay 16, 2019Melted; Material Deformation; Material Integrity Problem; Melted; Material Deformation; Material Integrity Problem
THE SHEATH OF THE ELECTRODE BLADE MELTED TWO SEPARATE TIMES DURING SEPARATE SURGERIES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8617653 ↗
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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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