DeRoyal 25-3001CRecalls & reported problems
Deroyal Industries, Inc. · SKIN STAPLER · 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 00749756677615), received between Oct 9, 2020 and Oct 9, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Form Staple” (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
- Failure to Form Staple1
- Mechanical Problem1
- Mechanics Altered1
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 9, 2020Mechanical Problem; Failure to Form Staple; Mechanics Altered; Mechanical Problem; Failure to Form Staple; Mechanics Altered
A PHYSICIAN WAS USING A SKIN STAPLER TO CLOSE A WOUND AND NEEDED 25-30 STAPLES. WHEN USING THE PRODUCT, HE SAID THE RIGHT SIDE OF THE STAPLE WOULD NOT CRIMP. FOUR STAPLERS WERE REQUIRED TO GET WHAT HE NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10657629 ↗
Other Stapler, surgical devices
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- ECHELON ECH60LEthicon Endo-Surgery, LLC · Stapler, surgical467 reports
- ECHELON ECH45SEthicon Endo-Surgery, LLC · Stapler, surgical269 reports
- EEA TRIEEA28XTCovidien LP · Stapler, surgical220 reports
- ECHELON ECH60CEthicon Endo-Surgery, LLC · Stapler, surgical197 reports
- ECHELON ECH45CEthicon Endo-Surgery, LLC · Stapler, surgical138 reports
- EEA TRIEEA31XTCovidien LP · Stapler, surgical73 reports
- ETHICON EC3D60LEthicon Endo-Surgery, LLC · Stapler, surgical39 reports
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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