Endo GIA 030418Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10884523002959), received between Oct 25, 2017 and Jan 15, 2025 — classified as 1 death, 5 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (17 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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, WHEN DISSOCIATING BLOOD VESSELS, THE TWO RELOADS DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. IT WAS NOTED THAT THE TWO RELOADS WERE USED FOR THE SAME PATIENT AND PROCEDURE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21155778 ↗
• MalfunctionJan 15, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, WHEN DISSOCIATING BLOOD VESSELS, THE TWO RELOADS DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. IT WAS NOTED THAT THE TWO RELOADS WERE USED FOR THE SAME PATIENT AND PROCEDURE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21155766 ↗
• MalfunctionDec 13, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, WHEN DETACHING THE TISSUE, THE TWO RELOADS WERE NOT ABLE TO FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. A NEW RELOAD WITH THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931144 ↗
• MalfunctionDec 13, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, WHEN DETACHING THE TISSUE, THE TWO RELOADS WERE NOT ABLE TO FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. A NEW RELOAD WITH THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20930788 ↗
• MalfunctionOct 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, WHEN BLOOD VESSELS WERE DETACHED, TWO RELOADS DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520553 ↗
• MalfunctionOct 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, WHEN BLOOD VESSELS WERE DETACHED, TWO RELOADS DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20520547 ↗
• MalfunctionDec 30, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDIX, DURING STAPLING, THE JAWS OF THE DEVICE CANNOT BE OPENED. A NEW KIT WAS USED TO RESOLVE THE ISSUE. THERE WAS O PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18422728 ↗
• MalfunctionJul 17, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT LOWER LOBECTOMY, AFTER LOADING THE DEVICE, THE TISSUE WAS CLAMPED, THE USER WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. HOWEVER, THE DEVICE DID NOT FIRE. A NEW RELOAD WITH THE SAME HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17334962 ↗
• InjuryNov 10, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LEFT LUNG TUMOR RESECTION UNDER GENERAL ANESTHESIA, WHEN THE LUNG TISSUE WAS TREATED WITH AN ENDOSCOPIC CUTTING STAPLER, THE FIRING PROCESS FAILED AFTER THE STAPLER CLAMPED THE LUNG TISSUE, THE STAPLER WAS FIRED ABOUT ONE-THIRD, THERE WERE STAPLES REMAINED IN THE RELOAD, AND IT WAS NOT ABLE TO CONTINUE THE FIRING AFTER, RESULTING IN INCOMPLETE CUTTING OF THE LUNG TISSUE AND INTRAOPERATIVE BLEEDING. THE SURGEON PRESSED THE GAUZE TO STOP THE BLEEDING. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE AND TO COMPLETE THE CUTTING OF LUNG TISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15776582 ↗
• MalfunctionSep 9, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LEFT UPPER LOBECTOMY, WHEN THE LEFT UPPER PULMONARY ARTERY AND THE LEFT UPPER LOBE INTERLOBAR FISSURE WERE DETACHED, THE DEVICE WAS ABLE TO FIRE ONE OF THE RELOADS BUT HAD A POOR STAPLE FORMATION, THE SHAPE OF THE STAPLE WAS NOT GOOD AND THE SUBSEQUENT FIRINGS COULD NOT BE MADE AFTER. THE SURGEON WAS ABLE TO PRESSED THE GREEN BUTTON BUT UNABLE TO SQUEEZED THE HANDLE. BLEEDING OCCURRED WHEN THE LEFT UPPER LOBE ARTERY WAS DETACHED. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397358 ↗
• MalfunctionAug 23, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT UPPER LOBECTOMY, WHEN RIGHT UPPER PULMONARY ARTERY AND INTERLOBAR FISSURE WAS PERFORMED, THE STAPLES DID NOT FORM B-SHAPE PROPERLY AND CAUSED BLEEDING. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275678 ↗
• MalfunctionAug 1, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT LOWER PULMONARY SEGMENTECTOMY, AFTER THE LOADING WAS COMPLETED, THE JAWS COULD BE OPENED AND CLOSED. WHEN THE DEVICE WAS READY TO FIRE, AFTER PRESSING THE FIRING SAFETY, WHEN THE PULMONARY BLOOD VESSELS WERE ABOUT TO BE DETACHED, THE DEVICE COULD NOT BE FIRED. A NEW RELOAD WAS USED TO RESOLVED THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 15142187 ↗
• InjuryMay 10, 2022Failure 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 A LAPAROSCOPIC CHOLECYSTECTOMY, WHEN THE DEVICE WAS APPLIED ON A BUNDLE OF A CYSTIC AND DUCTUS CHOLEDOCHUS, THE STAPLER WAS ABLE TO FIRE, THERE WAS POOR STAPLE FORMATION, ALL STAPLES WERE OPEN, THE WHOLE STAPLE LINE WAS INCOMPLETE CENTRALLY. THE OPEN STAPLES FELL INTO THE PATIENT CAVITY AND WERE RETRIEVED BY SUCTION. IT WAS NOTED THAT THE TISSUE WAS CLOSED WITH CLIPS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14350573 ↗
• MalfunctionJun 7, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE PULMONARY VEIN DURING A VIDEO ASSISTED THORACOSCOPIC SEGMENTECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE HANDLE WAS NOT SQUEEZED. THE STAPLER DID NOT FIRE. ANOTHER RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11951078 ↗
• MalfunctionMay 10, 2021Break; Detachment of Device or Device Component; Difficult to Open or Close; Break; Detachment of Device or Device Component; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE INNER SLIDE BROKE WHEN THE MAGAZINE WAS RELEASED, AND THE BROKEN PIECE HAD TO BE RETRIEVED FROM THE ABDOMINAL CAVITY. FURTHERMORE, THE CLAMPS ALSO HAD TO BE RETRIEVED FROM THE ABDOMINAL CAVITY, AS IT DID NOT CLOSE COMPLETELY WHEN RELEASED.

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

  MAUDE report 11796930 ↗
• MalfunctionApr 15, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, ON THE APPENDIX, THE SURGEON TRIED TO FIRE THE STAPLER, BUT FIRING WAS NOT POSSIBLE, THE HANDLE WAS NOT SQUEEZED. A NEW HANDLE AND RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671660 ↗
• MalfunctionApr 14, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, BY PLACING THE STAPLER AT THE APPENDIX BASE TISSUE OF THE CECUM, THE USER OPENED THE DEVICE JAWS TO PLACE THE STAPLER CLOSER TO THE TISSUE. THE USER CLOSED AGAIN. THE JAWS OF THE RELOAD SEEMED TO BE OPEN AND WAS NOT CLOSED COMPLETELY. THE SURGEON DECIDED TO OPEN THE SAME STAPLER AND CHANGE TO A 2ND RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11665240 ↗
• MalfunctionAug 11, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A LAPAROSCOPIC LEFT UPPER LOBECTOMY, WHEN THE DEVICE WAS ASSEMBLED, THE STAPLER WAS UNABLE TO FIRE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE STAPLE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10389802 ↗
• MalfunctionMay 13, 2020Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORASCOPIC LOBECTOMY PROCEDURE, WHEN THE DEVICE WAS APPLIED TO THE PULMONARY VEIN, THE STAPLER CAN BE FIRED BUT THE DISTAL STAPLES WERE NOT FORMED. THE IBEAM ALSO HAD BROKEN OFF AND FELL INTO THE CAVITY BUT WAS RETRIEVED. A NEW RELOAD WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10051479 ↗
• MalfunctionApr 21, 2020Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING A THORASCOPIC LOBECTOMY, WHEN THE PULMONARY VEIN IS BEING SEVERED, THE LOWER HALF OF THE I-BEAM IN THE NAIL CARTRIDGE USED TO CUT OFF THE BLOOD VESSEL BROKE BEFORE REACHING THE BLOOD VESSEL. IT WAS ALSO REPORTED THAT THE JAWS OF RELOAD COULD NOT BE CLOSED TIGHTLY. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9980342 ↗
• MalfunctionApr 16, 2020Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THORACOSCOPIC SURGERY RIGHT SUPERIOR LOBECTOMY, WHEN ON THE RIGHT UPPER LOBE OF THE LUNG, THE STAPLES BURST OUT WHEN THE INTERLOBAR FISSURE AND VEIN WERE REMOVED. THERE WAS POOR STAPLE FORMATION AND THE SUTURE WAS NOT SMOOTH. THE STAPLE LINE WAS INCOMPLETE PROXIMAL THAT WAS FIXED BY FIRING AGAIN WITH A NEW UNSEALED STAPLE. THE SURGEON REMOVED CRACKED PARTS AND STAPLES WITH A CAVITY MIRROR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9970642 ↗
• InjuryApr 1, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE FIRING WAS COMPLETED HOWEVER, WHEN THE SURGEON OPENED THE JAWS, THE STAPLE ON THE TISSUE WAS DEFORMED. OOZING BLEEDING OCCURRED AS A RESULT OF THE ISSUE. THE SURGEON HAD TO SUTURE THE TISSUE TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 9912831 ↗
• MalfunctionNov 5, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING OPEN LOBECTOMY PROCEDURE, FIRED STAPLES DID NOT FORMED IN B-SHAPED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9279382 ↗
• MalfunctionSep 18, 2019Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A SEGMENTECTOMY, ON THE RIGHT UPPER LOBE BLOOD VESSEL, THE STAPLER WAS ABLE TO FIRE AND THERE WAS A POOR STAPLE FORMATION. THE STAPLES COULD NOT FORM THE B-SHAPE. THEY CHANGED TO A NEW RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9084966 ↗
• InjuryJul 10, 2019Break; Failure to Fire; Detachment of Device or Device Component; Break; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, DURING FIRING, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. IT WAS REPORTED THAT SIX RELOADS BROKE AND FELL INTO THE PATIENT'S CAVITY. A GRASPER WAS USED TO REMOVE A PIECE OF TISSUE WITH OPEN STAPLES. NEW HANDLE AND RELOADS WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Tissue Damage

  MAUDE report 8778830 ↗

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-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-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-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-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-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-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-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-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-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-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-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-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT

…and 58 more.