GIA GIA60TMCRecalls & reported problems
Covidien LP · Cartridge with Tri-Staple Technology · Class 2 · Implant
All models of GIA (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521842670), received between Aug 28, 2024 and Sep 20, 2024 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Failure to Form Staple1
Patient problems
- Failure to Anastomose1
- No Clinical Signs, Symptoms or Conditions1
- Tissue Breakdown1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, POST-OPERATIVE A BOWEL RESECTION. THE PATIENT HAD A STAPLE LINE LEAK WHERE THE 3 STAPLERS WERE FIRED. THE PATIENT WENT BACK TO THE OPERATING ROOM TO HAVE AN OSTOMY.
Patient problems: Failure to Anastomose; Tissue Breakdown
MAUDE report 20270433 ↗MalfunctionAug 28, 2024Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, WHILE TESTING THE DEMO DEVICES PRIOR TO SHOWING IT TO SURGEONS, THE STAPLER WITH ITS PRELOADED RELOAD WAS HARD TO FIRE. NONETHELESS, IT WAS OBSERVED THAT ALL STAPLES WERE FIRED. A SECOND FIRING WAS THEN PERFORMED USING A NEW RELOAD. HOWEVER, IT WAS OBSERVED THAT ONE STAPLE WAS STUCK IN THE CARTRIDGE AND 5 STAPLE NAIL "HOUSES" DID NOT HAVE A PUSHER IN THEM AND DID NOT APPEAR TO HAVE RELEASED THE STAPLES. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20087382 ↗
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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