Multifire Endo GIARecalls & reported problems across all models
Covidien LP · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 163
- Deaths reported
- 1
- Injuries reported
- 29
- Recalls
- 0
We found 5 models of Multifire Endo GIA by Covidien LP in the FDA's device registry (GUDID). Together they are named in 163 adverse event reports in the FDA's MAUDE database, received between Apr 10, 2017 and Nov 13, 2023 — classified as 1 death, 29 injuries, 133 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (66 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Multifire Endo GIA problems
Device problems
- Failure to Fire66
- Difficult to Open or Close24
- Failure to Form Staple20
- Adverse Event Without Identified Device or Use Problem13
- Break12
- Entrapment of Device12
- Failure to Cut12
- Human-Device Interface Problem12
Patient problems
- No Known Impact Or Consequence To Patient78
- No Consequences Or Impact To Patient38
- No Code Available25
- No Clinical Signs, Symptoms or Conditions13
- Blood Loss9
- Tissue Damage9
- No Patient Involvement7
- No Information4
Multifire Endo GIA models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Multifire Endo GIA 030811STAPLE, IMPLANTABLE77 reports
- Multifire Endo GIA 030813STAPLE, IMPLANTABLE1 death71 reports
- Multifire Endo GIA 030805LSTAPLE, IMPLANTABLE10 reports
- Multifire Endo GIA 030807LSTAPLE, IMPLANTABLE4 reports
- Multifire Endo GIA 030331STAPLE, IMPLANTABLE1 report
Recent Multifire Endo GIA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING STAPLING OF THE ARTERY, THE HANDLE BLOCKED AND THE SURGEON WAS UNABLE TO FIRE. IT WAS NOTED THAT THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE HANDLE BROKE OFF. THE PATIENT WAS EXTENDED FOR HOSPITALIZATION BUT NOT DUE TO DEVICE ISSUE. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18124882 ↗MalfunctionNov 13, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PANCREATECTOMY PROCEDURE, DURING STAPLING OF THE ARTERY, THE JAWS LOCKED CORRECTLY ON THE ARTERY AND THE SURGEON WAS UNABLE TO FIRE. IT WAS BLOCKED. IT WAS NOTED THAT THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE AND THE HANDLE BROKE OFF. THE PATIENT WAS EXTENDED FOR HOSPITALIZATION BUT NOT DUE TO DEVICE ISSUE. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18121648 ↗InjurySep 24, 2022Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC ZENKER'S DIVERTICULUM, DURING TRANSECTION OF THE POUCH, THE DEVICE FIRED BUT THE STAPLES DID NOT DEPLOY PROXIMALLY. THE STAPLE LINE ON THE LEFT SIDE OF THE KNIFE BLADE WAS INCOMPLETE. LASER WAS USED TO SEAL THE OPENING TO FIX THE STAPLE LINE.
Patient problems: Unspecified Tissue Injury
MAUDE report 15480375 ↗InjurySep 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, EVEN WITHOUT EXCESSIVE FORCE, THE PRE-LOADED RELOAD BROKE APART WHILE IN USE INSIDE THE PATIENT¿S ABDOMINAL AREA LAPAROSCOPICALLY WHEN THE SURGEON WAS READY TO STAPLE. THE STAPLING CARTRIDGE WAS DETACHED FROM THE STAPLER¿S SHEATH COMPLETELY. THE DEVICE PARTS WERE RETRIEVED. NO BROKEN STAPLING PARTS WERE FOUND UPON INITIAL ASSESSMENT AND POST-OPERATIVE X-RAY IMAGING OF THE DIAPHRAGM AND ABDOMINAL REGIONS.
Patient problems: Unintended Radiation Exposure
MAUDE report 15420136 ↗MalfunctionJun 11, 2022Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING A HYSTERECTOMY AND BOWEL RESECTION PROCEDURE, THE DEVICE WILL CLOSE ONTO TISSUE BUT WOULD NOT TRIGGER FIRING ONTO THE TISSUE. ANOTHER STAPLING DEVICE WAS OPENED TO COMPLETE CASE AND RESOLVE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 14666433 ↗MalfunctionApr 28, 2022Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, WHILE AT BASE OF CECUM, THE DEVICE DID NOT FIRE. WHEN UNLOADING, THE DEVICE DID NOT RELEASE THE CLAMPS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14230057 ↗InjuryFeb 4, 2022Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING AN OPEN ZENKERS DIVERTICULECTOMY, ON TRANSECTION OF THE POUCH, THE RELOAD THAT CAME WITH THE STAPLE HANDLE FIRED SUCCESSFULLY. THE SECOND RELOAD THAT WAS LOADED ON TO THE STAPLE HANDLE FIRED STAPLES, BUT DID NOT CUT. THE SURGEON MANUALLY CUT BETWEEN THE STAPLE LINES TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 13458004 ↗InjuryAug 11, 2021Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER DURING LAPAROSCOPIC OVARIECTOMY, WHILE ON THE ABLATION OF OVARY, THE STAPLER DID NOT FIRE. THE SURGEON ACTIVATES THE FORCEPS TO PLACE THE STAPLES, NOTHING HAPPENS. THE ACTION IS REPEATED AGAIN BUT STILL NO STAPLES. AS A RESULT, THE PATIENT EXPERIENCED RED PINCHING ON THE OVARY AND TISSUE DAMAGE. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WAS USED BY THE SURGEON TO COMPLETE THE CASE.
Patient problems: Unspecified Tissue Injury
MAUDE report 12309198 ↗MalfunctionJul 8, 2021Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, THE DEVICE COULD NOT BE FIRE. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12137850 ↗InjuryJun 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, DURING OPEN NEPHRECTOMY, WHEN DIVIDING THE RENAL VEIN AND RENAL ARTERY, AND TAKING AWAY THE KIDNEY, THE STAPLE LINE WAS FOUND BLEEDING AND THE PATIENT LOST 500 CC OF BLOOD. TO RESOLVE THE BLEEDING, THE VASCULAR SURGEON USED SUTURE TO CLOSE THE VESSEL AND BLOOD TRANSFUSION WAS GIVEN TO THE PATIENT. DUE TO DEVICE MALFUNCTION, THE SURGICAL PROCEDURE WAS EXTENDED FOR MORE THAN 30 MINUTES.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury
MAUDE report 11958678 ↗MalfunctionMay 5, 2021Difficult to Open or Close; Difficult to Open or Close
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RESECTION OF THE APPENDIX, THE JAWS COULD NOT BE OPEN. ANOTHER DEVICE WAS USED TO COM PLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11776753 ↗MalfunctionMay 3, 2021Misfire; Misfire
ACCORDING TO THE REPORTER, THE DEVICE FIRED INCORRECTLY.
Patient problems: Insufficient Information
MAUDE report 11766814 ↗MalfunctionFeb 9, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON TRIED TO SQUEEZE THE HANDLE TO STAPLE, THE SPRING DETAC HED/DROPPED WHEN OPENING THE JAWS RENDERING IT UNUSABLE. ANOTHER STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11300134 ↗MalfunctionDec 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, SMALL BLUE PLASTIC PART FROM THE RELOAD BROKE AND FELL INTO THE CAVITY. THE SAID PART WAS RETRIEVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11094440 ↗MalfunctionDec 18, 2020Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC CHOLECYSTECTOMY, WHILE STAPLING THE CYSTIC DUCT, THE SURGEON PLACED THE DEVICE AND WAS THEN UNABLE TO SQUEEZE THE HANDLE TO FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11037808 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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