Endo GIA EGIARADMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 168 adverse event reports that list this exact device (DI 10884521057784), received between Apr 5, 2017 and Dec 12, 2025 — classified as 20 injuries, 148 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (77 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825, K131705); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 168 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Failure to Fire; Mechanics Altered; Failure to Fire; Mechanics Altered

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, AFTER FIRING TO RESECT A SMALL LUNG TISSUE FOR A FROZEN TISSUE TEST, THE FIRING COMPLETED TONE WAS HEARD BUT THE TISSUE WAS NOT CUT AND THE STAPLES WERE NOT DEPLOYED. THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 23796796 ↗
• MalfunctionJun 30, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHILE SETTING-UP THE DEVICE AND TESTING THE RELOAD, THERE WAS A LOADING ISSUE. ADDITIONALLY, THE DEVICE DID NOT ARTICULATE. A NEW LOAD AND STAPLER WAS USED, BUT THE RELOAD DID NOT FIRE WHEN ATTEMPTING TO USE IT. TO RESOLVE THE ISSUE, A THIRD RELOAD WAS USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365599 ↗
• MalfunctionSep 19, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE RECTOSIGMOIDECTOMY, WHEN STAPLING THE TISSUE, THE STAPLER DID NOT FIRE. AFTER SEVERAL ATTEMPTS, BOTH THE HANDLE AND RELOAD WERE REPLACED. THE SURGICAL TIME WAS EXTENDED FOR AN HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261238 ↗
• MalfunctionMay 10, 2024Break; Failure to Fire; Break; Failure to Fire

  ACCORDING TO THE CLINICAL STUDY, IN A SIGMOIDECTOMY WITH COLOSTOMY, THE RELOAD FAILED DURING USE. THE DEVICE DID NOT STAPLE CORRECTLY. THE DEVICE WAS UNABLE TO FIRE. THE LOAD FAILURE PREVENTED THE STAPLER FROM FUNCTIONING CORRECTLY AND THE MECHANISM FROM BEING BROKEN. ANOTHER HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 19288813 ↗
• MalfunctionMar 19, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION, WHEN FIRING FOR THE LARGE INTESTINE, THE STAPLER DID NOT FIRE. THE RELOAD GOT JAMMED AND THE STAPLES DID NOT COME OUT. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933912 ↗
• MalfunctionJan 17, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, THE RELOAD DID NOT OPEN. THE SURGEON STARTED THE STAPLING PROCEDURE AWAY FROM THE PATIENT IN ORDER TO OPEN THE STAPLER. TO COMPLETE THE CASE, ANOTHER RELOAD WAS USED WITH THE SAME HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18531006 ↗
• MalfunctionOct 16, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN AN OPEN LOWER ANTERIOR RESECTION, DURING THE APPLICATION OF THE DEVICE IN THE RECTUM, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. THE RELOAD WAS REMOVED AND REPLACED WITH AN ARTICULATING RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940656 ↗
• MalfunctionOct 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC ABDOMINAL RECTOSIGMOIDECTOMY, AT THE TIME OF RECTUM RESECTION, THE MANUAL STAPLER WAS WORKING WELL UNTIL IT WAS USED WITH THE PURPLE RADIAL RELOAD. THE HANDLE WAS SOFT, AND THE STAPLER DID NOT FIRE. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17878245 ↗
• MalfunctionSep 20, 2023Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN AN OPEN RESECTION OF THE COLORECTAL SIGMOID, DURING THE RESECTION OF THE RECTUM, WHEN THE DEVICE WAS FIRED, THE RELOAD CUT BUT DID NOT DEPLOY STAPLES AT ALL. THE RECTUM WAS DAMAGED AND BECAME TOTALLY OPEN AS A RESULT. THE SURGICAL TIME WAS EXTENDED FOR 30 MINUTES MORE TO CLOSE THE RECTUM MANUALLY WITH WIRE SUTURE TO RESOLVE THE ISSUE. THE INCISION WAS ALSO EXTENDED BY LESS THAN AN INCH.

  Patient problems: Tissue Breakdown; Unspecified Tissue Injury

  MAUDE report 17781192 ↗
• MalfunctionJul 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN COLOSTOMY, LOOSE STAPLES FELL IN PATIENT CAVITY. IT WAS AT THE TIME OF PLACING THE DEVICE IN THE INTESTINE, THAT IT WAS NOTICED THAT THERE WERE LOOSE STAPLES IN THE INTESTINE, WITHOUT HAVING ACTIVATED THE DEVICE. THE DOCTOR DECIDED NOT TO ACTIVATE THE DEVICE SINCE LOOSE STAPLES WERE SEEN IN THE INTESTINE THAT DOCTOR WAS GOING TO STAPLE. LOOSE STAPLES WERE RETRIEVED. THE RELOAD WAS REPLACED AND SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17249642 ↗
• MalfunctionApr 19, 2023Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SIGMOID RESECTION, DURING THE FIRING OF RADIAL RELOAD ACROSS THE RECTUM, THE STAPLE HAD POOR FORMATION AND THE DEVICE WAS DIFFICULT TO FIRE DUE TO TOO MUCH TISSUE CAUSING THE HANDLE TO CRACK. THE SURGEON THOUGHT THAT THE HANDLE WAS BROKEN. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770511 ↗
• MalfunctionNov 15, 2022Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING THE OPEN ABDOMINOPERINEAL RESECTION, THE STAPLER DID NOT FIRE NEAR THE RECTUM. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THERE WAS ALSO PROBLEM WHEN UNLOADING, THE RELOAD GOT STUCK. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798902 ↗
• MalfunctionOct 7, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC WEDGE RESECTION PROCEDURE, WHEN PERFORMING THE RESECTION OF RIGHT LOBE OF LUNG, WHEN LOADING THE RELOAD TO THE STAPLER, THE SURGEON REMOVED THE YELLOW SHIPPING WEDGE, TEST THE CORRECTION OF ASSEMBLY BY CLOSING AND OPENING THE JAW. THE SURGEON CLAMPED ON THE TISSUE. WHEN COMPLETING THE CLAMPING, THE SURGEON PRESSED THE GREEN BUTTON, THE LOOP HANDLE WAS RELEASED BUT COULD NOT BE SQUEEZED. THE BLACK WINGS DID NOT ADVANCE ON THE HANDLE. THE SURGEON USED RELATIVELY STRONG FORCE, BUT THE LOADING COULD NOT BE FIRE. TO RESOLVE THE ISSUE, THE SURGEON REPLACED BY ANOTHER RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15564150 ↗
• MalfunctionSep 13, 2022Component Missing; Component Missing

  ACCORDING TO THE REPORTER, DURING THE PARTIAL LOBECTOMY, WHILE ON LUNG RESECTION, THE RADIAL RELOAD WAS USED FOR THE 5TH FIRING, AFTER COMPLETING THE FIRING STEPS AS USUAL, WHEN RETRACTED AND JAWS OPENED, THE SURGEON REALIZED THAT THE RELOAD WAS NOT FIRING SUCCESSFULLY, THE SURGEON FOUND NO STAPLES FIRED INTO TISSUE AND NO CUT LINE ON THE TISSUE AS WELL. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411873 ↗
• MalfunctionAug 10, 2022Difficult or Delayed Positioning; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, AT THE TIME OF STAPLER FIRING, THERE WAS A POOR STAPLE FORMATION, THE STAPLER STUCK WHILE FIRING AND THE STAPLE LINE WERE LOOSE. A NEW RELOAD WAS USED TOP COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201226 ↗
• MalfunctionMay 31, 2022Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, ON STAPLING, THE STAPLER WAS UNABLE TO FIRE, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE, THERE WAS A PROBLEM UNLOADING THE DEVICE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14550489 ↗
• MalfunctionJan 12, 2022Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN REMOVING THE AFFECTED TISSUE DURING A LAPAROSCOPIC PNEUMOTHORAX, DEVICE OPENED AND CLOSED OUTSIDE THE PATIENT WHEN IT WAS INSERTED THROUGH THE TROCAR, IT NO LONGER OPENED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236956 ↗
• InjuryDec 29, 2021Failure to Form Staple; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL THYROIDECTOMY, WHILE IN THE LUNG, THE 1ST LOAD DID NOT STAPLE WELL AND BROKE OFF, THE 2ND LOAD DID NOT ADVANCE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. IT WAS NOTED THE VEIN WAS LEAKING AND STAPLES WERE LEFT IN THE DEVICE. PART OF THE STAPES FELL OFF. A NEW RELOAD, SUTURE AND ANOTHER CLIP AND THE SAME HANDLE WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13112372 ↗
• MalfunctionOct 18, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY BY VIDEO, WHEN THE GREEN BUTTON WAS UNLOCKED, THE HANDLE WAS LOOSE AND WAS NOT POSSIBLE TO FIRE. BOTH STAPLER AND RELOAD WERE REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12647905 ↗
• MalfunctionSep 3, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTOSIGMOIDECTOMY, AT THE BEGINNING OF THE SURGERY, THE LOAD WAS PROPERLY MOUNTED, BUT DID NOT FIRE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND COULD SQUEEZE THE HANDLE. THE LOAD WAS REPLACED AND THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421977 ↗
• MalfunctionSep 2, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING RECTOSIGMOIDECTOMY AND LYMPHADENECTOMY, THE RELOAD WAS BEING USED ON THE STAPLER, BUT WHEN TRIGGERED IT FAILED TO FIRE. IT WAS REPLACED WITH A CLAMP AND CIRCULAR STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413426 ↗
• MalfunctionAug 3, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOW ANTERIOR RESECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE TO SQUEEZE THE HANDLE. THE DEVICE DID NOT FIRE. IT WAS ALSO NOTED THAT THE HANDLE BROKE OFF. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12267245 ↗
• MalfunctionJul 28, 2021Entrapment of Device; Misfire; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW RECTAL CANCER RESECTION, NORMAL ASSEMBLING WAS PERFORMED, EMPTYING THE STAPLES IN THE HANDLE AND PRE-FIRING WERE NORMAL, AND COULD BE CLAMPED NORMALLY. AFTER FIRING A LITTLE BIT, IT GOT STUCK ON TISSUE. AFTER PULLING THE PUSH BUTTON FORCEFULLY, THE DEVICE COULD BE EXITED, BUT IT COULD NOT BE FIRED AGAIN. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12240105 ↗
• MalfunctionJul 7, 2021Misfire; Device Displays Incorrect Message; Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, WHEN STAPLING THE INTESTINAL LOOP DURING A LAPAROSCOPIC RETOSYNTHICTOMY, THE SURGEON REPOSITIONED THE TISSUE AND THE DEVICE¿S TRIGGER SIGNALED THAT THE DEVICE WAS READY FOR FIRING. HOWEVER, THE FIRST LOAD THAT WAS USED DID NOT NEITHER STAPLE NOT CUT. THE DEVICE SIGNALED ZEROED LOAD THEN. A SECOND LOAD OF THE SAME BATCH WAS OPENED WHICH STAPLED HALFWAY AND LEFT THE STAPLER LINE OPEN AND DEVICE SIGNALED ZERO LOAD AGAIN WITHOUT FULLY STAPLING. THE SURGEON THEN USED ANOTHER STAPLER AND TWO RELOADS THAT ALSO DID NOT COMPLETE THE STAPLING ON THE TISSUE. THE STAPLER LOCKED AND DID NOT WORK. TO FINISH THE PROCEDURE THE SURGEON REVERTED TO OPEN VIA ANAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12129975 ↗
• MalfunctionJun 15, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER DURING THE RECTOSIGMOIDECTOMY PROCEDURE, AT THE TIME THAT THE STAPLING WAS DONE THE LOAD STOPPED MAKING IT IMPOSSIBLE TO STAPLE THE TISSUE. TO COMPLETE THE PROCEDURE ANOTHER LOADING UNIT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12003097 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825, K131705. One submission often covers many models, so check the product and lot details in each record.

• Z-0748-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection
• Z-0747-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or tra
• Z-0008-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0009-2021 · Aug 12, 2020 · Open, Classified
  Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applicat
• Z-0002-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0004-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0007-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic
• Z-0001-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gyn
• Z-0003-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0005-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric
• Z-0006-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-1264-2020 · Jan 17, 2020 · Terminated
  Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

…and 58 more.