GIA GIA80MTSRecalls & reported problems
Covidien LP · Medium/Thick Stapler with Tri-Staple Technology · Class 2
Quick summary
This Covidien GIA medium-thick surgical stapler has 263 adverse event reports, including 208 malfunctions, 54 injuries and 1 death. Reports mostly describe the stapler not firing or not forming staples, misfiring, and parts coming loose during surgery, and some mention tissue breakdown, bleeding, and failed connections between tissues. There are no recalls that name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 264
- Deaths reported
- 1
- Injuries reported
- 52
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 264 adverse event reports that list this exact device (DI 10884521723450), received between Mar 30, 2021 and Sep 29, 2026 — classified as 1 death, 52 injuries, 211 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (69 reports).
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
- Failure to Fire69
- Adverse Event Without Identified Device or Use Problem49
- Failure to Form Staple42
- Misfire39
- Detachment of Device or Device Component34
- Break20
- Retraction Problem11
- Failure to Cut10
Patient problems
- No Clinical Signs, Symptoms or Conditions140
- Tissue Breakdown43
- Failure to Anastomose39
- Insufficient Information39
- Unspecified Tissue Injury31
- Hemorrhage/Blood Loss/Bleeding16
- Bowel Perforation9
- Unspecified Infection8
Recent adverse event reports
The 25 most recent of 264 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934472 ↗MalfunctionSep 22, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859123 ↗MalfunctionSep 21, 2026Retraction Problem
Patient problems: Insufficient Information
MAUDE report 50849016 ↗MalfunctionSep 21, 2026Failure to Fire
It was reported that during a procedure, the stapler instrument did not fire. The device was replaced with a new product to resolve the issue. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839439 ↗MalfunctionSep 17, 2026Misfire
According to the reporter, during a transverse colectomy, when performing functional end-to-end (FEEA) anastomosis, when it was used for closure of the insertion hole on the fourth firing, the firing knob became too hard midway and could no longer be advanced. Upon confirmation, forceps and the like were not caught inside. Hence, it could not be advanced; the firing knob was returned. To resolve the issue, a new stapler and cartridge were taken out and used, and resection was performed.
Patient problems: Failure to Anastomose
MAUDE report 50805313 ↗MalfunctionSep 16, 2026Mechanics Altered
Patient problems: Tissue Breakdown
MAUDE report 50793267 ↗MalfunctionSep 15, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778225 ↗MalfunctionAug 18, 2026Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307145 ↗MalfunctionAug 18, 2026Failure to Form Staple
Patient problems: Tissue Breakdown
MAUDE report 50303893 ↗MalfunctionAug 14, 2026Misfire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256395 ↗MalfunctionAug 7, 2026Misfire; Mechanical Jam
Patient problems: Insufficient Information
MAUDE report 50168713 ↗MalfunctionJun 22, 2026Failure to Form Staple; Mechanics Altered
IT WAS REPORTED THAT, DURING A LIVER SURGERY, THE STAPLER WAS USED FOR AN ANASTOMOSIS, THE STAPLES DID NOT DEPLOYED TO FORM A PROPER B-SHAPE AND THE BLADE CUT TISSUE. BLEEDING WAS REPORTED BECAUSE THE TISSUE WAS CUT WITHOUT STAPLING. THE DEVICE WAS REPLACED DURING THE PROCEDURE BY USING ANOTHER STAPLER. THE PROCEDURE WAS PROLONGED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown
MAUDE report 25587718 ↗MalfunctionJun 20, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLER DID NOT FIRE ALL STAPLES THAT CAUSE THE INSUFFICIENT SEAL. RESECTION WAS PERFORMED TO ADDRESS THE STAPLE LINE ISSUE, AND RE-STAPLING WAS PERFORMED. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY FIFTEEN MINUTES.
Patient problems: Tissue Breakdown
MAUDE report 25571658 ↗MalfunctionMay 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PROCEDURE, WHEN USING THE DEVICE, THE TRIGGER RELEASED AND IT DISENGAGED FROM THE STAPLER. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25072844 ↗MalfunctionMay 4, 2026Mechanics Altered
IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE INVOLVING RESECTION OF THE STOMACH, THE STAPLES DID NOT DEPLOY (CUT WITHOUT STAPLING). THE DEVICE WAS REPLACED WITH ANOTHER MANUFACTURER¿S STAPLER TO RESOLVE THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 25070839 ↗MalfunctionApr 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A GASTRIC RESECTION PROCEDURE, AN OPEN STAPLER WAS USED AND, AFTER FIRING, THE STAPLE LINE BURST OPEN AND A STAPLE LINE LEAK WAS OBSERVED WITH LEAKAGE OF THE CONTENTS BEING HELD BY THE TISSUE, WHICH WAS DISCOVERED DURING THE PROCEDURE. A LEAK TEST RESULT WAS RECORDED AS NOT AVAILABLE. THE REPORTED PATIENT IMPACT WAS UNKNOWN, AND NO PATIENT SYMPTOMS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 24923182 ↗MalfunctionMar 23, 2026Failure to Form Staple; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A COLON RESECTION, THE STAPLE LINE FROM THE STAPLER AND TWO ADDITIONAL RELOADS WAS INCOMPLETE. TO RESOLVE THE ISSUE, A PURPLE RELOAD, WHICH WAS NOT INDICATED FOR USE IN THE COLON, WAS UTILIZED TO COMPLETE THE COLON RESECTION.
Patient problems: Tissue Breakdown
MAUDE report 24664910 ↗MalfunctionMar 23, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A PROCEDURE, PRIOR TO FIRING, THE TIP PART OF THE STAPLER WAS DAMAGED DURING DISASSEMBLY OF THE BASE MOUNTED CARTRIDGE AND BROKE OFF. ANOTHER SAME TYPE OF INSTRUMENT WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24663563 ↗MalfunctionMar 20, 2026Protective Measures Problem
IT WAS REPORTED THAT PREOPERATIVELY, WHEN THE DEVICE WAS PASSED TO THE SURGEON, THE BLADE WAS ALREADY ON WITHOUT ACTIVATING THE DEVICE. THE CARTRIDGE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24656515 ↗MalfunctionMar 13, 2026Failure to Fire
IT WAS REPORTED THAT DURING A DIGESTIVE SURGERY, WHEN THE SURGEON ATTEMPTED TO STAPLE, THE RELOAD WAS STUCK AND COULD NOT BE USED. ANOTHER DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592559 ↗MalfunctionMar 11, 2026Break
IT WAS REPORTED THAT DURING A PROCEDURE, WHILE THE TECHNICIAN WAS ASSEMBLING THE DEVICE, IT WAS OBSERVED THAT THE AREA WHERE THE RELOAD MECHANISM WAS INSERTED WAS BROKEN. THE DEVICE WAS NOT THEN USED. TO RESOLVE THE ISSUE, A NEW STAPLER WAS USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24570555 ↗MalfunctionMar 7, 2026Failure to Fire
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE OPEN STAPLER, THE INSTRUMENT DID NOT FIRE, WHICH RESULTED IN AN EXTENDED SURGICAL TIME OF 30 MINUTES. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 24540731 ↗MalfunctionMar 7, 2026Failure to Fire
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE OPEN STAPLER, THE INSTRUMENT DID NOT FIRE, WHICH RESULTED IN AN EXTENDED SURGICAL TIME OF 30 MINUTES. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 24540518 ↗MalfunctionMar 7, 2026Failure to Fire
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE OPEN STAPLER, THE INSTRUMENT DID NOT FIRE, WHICH RESULTED IN AN EXTENDED SURGICAL TIME OF 30 MINUTES. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT TO ADDRESS THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 24539738 ↗MalfunctionMar 4, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING HEMICOLECTOMY AND ILEOCOLIC ANASTOMOSIS, AN INCOMPLETE STAPLE LINE WAS NOTED. THERE WAS NO CONTINUITY OF STAPLES IN TWO SEGMENTS, RESULTING IN INTESTINAL CONTENT LEAKAGE. THE AFFECTED INTESTINAL SEGMENT REQUIRED MANUAL RESECTION AND ANASTOMOSIS.
Patient problems: Failure to Anastomose
MAUDE report 24512953 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.