Tri-Staple 2.0 SIGC60VRecalls & reported problems
Covidien LP · Cartridge · Class 2 · Implant
All models of Tri-Staple 2.0 (37)
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 10884521543546), received between Dec 1, 2021 and Dec 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Fire” (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
- Failure to Fire1
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.
MalfunctionDec 1, 2021Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX EN Y, WHILE PERFORMING A SMALL BOWEL ANASTOMOSIS, THE DEVICE ENTERED FIRING MODE BUT DID NOT FIRE ON FIVE CARTRIDGE'S. ON THE LAST SIXTY MILLIMETER LOADING UNIT, THE SURGEON WAS NOT ABLE TO SQUEEZED THE HANDLE AFTER PRESSING THE GREEN BUTTON. TO RESOLVE THE ISSUE, THE SURGEON USED A COMPETITOR'S DEVICE. THE SURGERY GOT EXTENDED FOR THIRTY MINUTES. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12909790 ↗
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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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