EEA TRIEEA21MTRecalls & reported problems
Covidien LP · Circular Stapler with Tri-Staple Technology · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521592988), received between Feb 18, 2025 and Aug 28, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove1
- Failure to Cut1
- Failure to Fire1
- Failure to Form Staple1
- Human-Device Interface Problem1
- Misassembly by Users1
- Product Quality Problem1
Patient problems
- Failure to Anastomose2
- Tissue Breakdown2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Difficult to Remove
Patient problems: Failure to Anastomose; Tissue Breakdown
MAUDE report 50496258 ↗InjuryApr 15, 2026Failure to Form Staple; Failure to Cut; Misassembly by Users
IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL RESECTION FOR COLON CANCER INVOLVING TRANSECTION OF THE RIGHT HEMICOLON AND DIGESTIVE TRACT RECONSTRUCTION, A 60 MM MANUAL LINEAR PURPLE STAPLER JAMMED MID FIRING. MOREOVER, A CIRCULAR STAPLER WAS ASSOCIATED WITH POOR STAPLE FORMATION AND INCOMPLETE CUTTING AFTER FIRING. AN IMPROPERLY MATCHED INSTRUMENT AND ANVIL COMBINATION WAS USED. RESECTION AND RE-STAPLING WERE PERFORMED TO FIX THE STAPLE LINE, AND THE STAPLER WAS REPLACED TO RE-ANASTOMOSE AND COMPLETE THE CASE. AN ADDITIONAL OPERATION TO CORRECT THE ISSUE WAS REPORTED.
Patient problems: Failure to Anastomose; Tissue Breakdown
MAUDE report 24889458 ↗MalfunctionSep 18, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT INTRAOPERATIVELY, FIRE FAILURE OCCURRED WITH THE CIRCULAR STAPLER DURING USE.
Patient problems: Insufficient Information
MAUDE report 23089642 ↗MalfunctionFeb 18, 2025Product Quality Problem; Human-Device Interface Problem; Product Quality Problem; Human-Device Interface Problem
IT WAS REPORTED THAT DURING AN ESOPHAGOJEJUNOSTOMY/ ESOPHAGOJEJUNAL ANASTOMOSIS IN TOTAL GASTRECTOMY, THE KNOB OF THE CIRCULAR STAPLER WAS TIGHTENED TO THE END, BUT THE GREEN MARK DID NOT APPEAR. THE SAFETY LEVER COULD BE RELEASED, SO IT WAS FIRED AS IS, AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21392234 ↗
Other Stapler, surgical devices
- ECHELON ECH60SEthicon Endo-Surgery, LLC · Stapler, surgical1 death631 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.