Endo GIA EGIA60AVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,438 adverse event reports that list this exact device (DI 10884523003222), received between Jul 15, 2016 and Sep 29, 2026 — classified as 9 deaths, 286 injuries, 1,143 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (570 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825); 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 1,438 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941030 ↗
• MalfunctionSep 28, 2026Misfire

  It was reported that during a procedure, the device had unknown firing issue. A new reload was used to resolve the issue.

  Patient problems: Insufficient Information

  MAUDE report 50919318 ↗
• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: Insufficient Information

  MAUDE report 50917451 ↗
• MalfunctionSep 18, 2026Failure to Fire

  It was reported that during a laparoscopic general surgery procedure for tissue cutting and closure, the stapler green button could be pressed; however, the surgeon was unable to squeeze the handle, and the stapler was unable to fire. The device was replaced withanother reload 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 50818381 ↗
• MalfunctionSep 1, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50543968 ↗
• MalfunctionAug 12, 2026Failure to Fire

  According to the reporter, during a thoracoscopic lobectomy, during lung resection, the stapler did not fire. The handle and the reload were replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220555 ↗
• MalfunctionAug 12, 2026Failure to Fire

  According to the reporter, during a thoracoscopic bullectomy, during transection pulmonary bullae, the stapler did not fire. The handle and the reload were replaced to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220417 ↗
• MalfunctionAug 10, 2026Failure to Form Staple

  Patient problems: Tissue Breakdown

  MAUDE report 50191611 ↗
• MalfunctionAug 5, 2026Misfire

  Patient problems: Insufficient Information

  MAUDE report 50144950 ↗
• MalfunctionJun 4, 2026Misfire

  IT WAS REPORTED THAT, DURING THE PROCEDURE, PARTIAL FIRE OCCURRED INVOLVING THE HANDLE AND THE THREE RELOADS. THE SURGICAL TIME WAS EXTENDED AS A RESULT. THE DEVICE WAS REPLACED, AND A NEW HANDLE AND NEW RELOADS WERE 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 25394417 ↗
• MalfunctionJun 4, 2026Misfire

  IT WAS REPORTED THAT, DURING THE PROCEDURE, PARTIAL FIRE OCCURRED INVOLVING THE HANDLE AND THE THREE RELOADS. THE SURGICAL TIME WAS EXTENDED AS A RESULT. THE DEVICE WAS REPLACED, AND A NEW HANDLE AND NEW RELOADS WERE 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 25394272 ↗
• MalfunctionJun 4, 2026Misfire

  IT WAS REPORTED THAT, DURING THE PROCEDURE, PARTIAL FIRE OCCURRED INVOLVING THE HANDLE AND THE THREE RELOADS. THE SURGICAL TIME WAS EXTENDED AS A RESULT. THE DEVICE WAS REPLACED, AND A NEW HANDLE AND NEW RELOADS WERE 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 25394086 ↗
• MalfunctionMay 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED LAPAROSCOPIC SMALL GASTRIC BYPASS, THE DEVICE WAS SLOWLY PULSED FIRED WITH 5-10 PAUSES IN BETWEEN. WHEN THE DEVICE REACHED THE END OF FIRING, THE SURGEON PAUSED FOR 30 SECONDS TO MAKE SURE THAT THE TISSUE WAS FULLY RELAXED BEFORE RETRACTING THE BLADE. THE BLEEDING APPEARED 15 MINUTES LATER THROUGH OUT THE ENTIRE STAPLE LINE FOR THE GASTRIC POUCH. A TOTAL OF FIVE RELOADS WERE USED. ALL CLIPS FROM THE CLIP APPLIER WERE USED TO STOP THE BLEEDING. IT WAS NOTED THAT THE TISSUE FELT NORMAL WHEN FIRING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25073838 ↗
• MalfunctionApr 29, 2026Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE POWERED STAPLER DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030205 ↗
• MalfunctionMar 31, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN ILEUS, AFTER PRESSING THE GREEN RELEASE BUTTON, THE HANDLE COULD NOT BE SQUEEZED, AND THE DEVICE DID NOT FIRE. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 15 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742455 ↗
• MalfunctionMar 31, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, DURING DETACHMENT OF THE INTERLOBAR FISSURE, UPON PRESSING THE HANDLE HALFWAY, AN AUDIBLE CLICK WAS HEARD; SUBSEQUENT ATTEMPTS TO PRESS THE HANDLE ELICITED NO RESPONSE. THE RELOAD WAS FOUND TO BE PARTIALLY FIRED. 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 24742282 ↗
• MalfunctionMar 30, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS, THE STAPLES DID NOT FORM CORRECTLY. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT TO ADDRESS THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24728773 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE OPERATED PATIENT PRESENTED A COMPLICATION IN THE POSTOPERATIVE BYPASS PROCEDURE, THE PATIENT DEVELOPED A GASTRIC LEAK, THE PATIENT ADMITTED TO THE ICU. A EXPLORATORY SURGERY PERFORMED. A MECHANICAL VENTILATION. VASOACTIVE DRUGS.

  Patient problems: Failure to Anastomose

  MAUDE report 24724621 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE OPERATED PATIENT PRESENTED A COMPLICATION IN THE POSTOPERATIVE BYPASS PROCEDURE, THE PATIENT DEVELOPED A GASTRIC LEAK, THE PATIENT ADMITTED TO THE ICU. A EXPLORATORY SURGERY PERFORMED. A MECHANICAL VENTILATION. VASOACTIVE DRUGS.

  Patient problems: Failure to Anastomose

  MAUDE report 24724491 ↗
• MalfunctionMar 30, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING SET-UP PRIOR TO FIRING, THE JAWS OF THE STAPLER WOULD NOT OPEN OR CLOSE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711544 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING GASTRIC BYPASS SURGERY, THE PATIENT EXPERIENCED GASTROINTESTINAL BLEEDING ON THE THIRD DAY POS T-PROCEDURE. THE PATIENT WAS READMITTED TO THE HOSPITAL FOR TWO DAYS AND PRESENTED WITH MELENA BLEEDING. AN ENDOSCOPY WAS PERFORMED, AND NO ACTIVE BLEEDING WAS OBSERVED AT THAT TIME. PLASMA WAS ADMINISTERED AS A PROPHYLACTIC METHOD.

  Patient problems: Gastrointestinal Hemorrhage; Melena

  MAUDE report 24708865 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER UNDERGOING GASTRIC BYPASS SURGERY, THE PATIENT EXPERIENCED GASTROINTESTINAL BLEEDING ON THE THIRD DAY POS T-PROCEDURE. THE PATIENT WAS READMITTED TO THE HOSPITAL FOR TWO DAYS AND PRESENTED WITH MELENA BLEEDING. AN ENDOSCOPY WAS PERFORMED, AND NO ACTIVE BLEEDING WAS OBSERVED AT THAT TIME. PLASMA WAS ADMINISTERED AS A PROPHYLACTIC METHOD.

  Patient problems: Gastrointestinal Hemorrhage; Melena

  MAUDE report 24708843 ↗
• MalfunctionMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ROBOTIC ASSISTED SLEEVE TO GASTRIC BYPASS CONVERSION PROCEDURE, BEFORE CREATING THE JEJUNOJEJUNAL AN ASTOMOSIS, THE TWO RELOADS WERE APPLIED FOR THE FIRST TRANSECTION, AND 20 MINUTES LATER, STAPLE LINE BLEEDING OCCURRED. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT TO RESOLVE THE STAPLE LINE BLEEDING.

  Patient problems: Tissue Breakdown

  MAUDE report 24645254 ↗
• MalfunctionMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE ROBOTIC ASSISTED SLEEVE TO GASTRIC BYPASS CONVERSION PROCEDURE, BEFORE CREATING THE JEJUNOJEJUNAL AN ASTOMOSIS, THE TWO RELOADS WERE APPLIED FOR THE FIRST TRANSECTION, AND 20 MINUTES LATER, STAPLE LINE BLEEDING OCCURRED. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT TO RESOLVE THE STAPLE LINE BLEEDING.

  Patient problems: Tissue Breakdown

  MAUDE report 24644877 ↗
• MalfunctionMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC ASSISTED SURGERY FOR SMALL GASTRIC POUCH BYPASS, STAPLE LINE BLEEDING WAS OBSERVED 10¿15 MINUTES AFTER FIRING FOUR RELOADS. SUTURING WAS PERFORMED AS REINFORCEMENT AND CLIP APPLIERS WERE REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24635624 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825. 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-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-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-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-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-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-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-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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

…and 58 more.