Endo GIA EGIATRS60AXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 221 adverse event reports that list this exact device (DI 10884521191006), received between Jan 5, 2017 and Jul 10, 2025 — classified as 22 injuries, 199 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (104 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. 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 221 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A DISTAL PANCREATOMY PROCEDURE INVOLVING THE RELOAD, THERE WERE STAPLE FORMATION ISSUE. THE PROCEDURE WAS EXTENDED BY ONE HOUR AS A RESULT. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT TO ADDRESS THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22476013 ↗
• MalfunctionJan 15, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BOTH RELOAD ONLY FIRED FOR ABOUT 15MM THEN IT GOT STUCKED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164252 ↗
• MalfunctionJan 15, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, BOTH RELOAD ONLY FIRED FOR ABOUT 15MM THEN IT GOT STUCKED. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES DUE TO THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164246 ↗
• MalfunctionJan 2, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DISTAL STAPLES WERE POORLY FORMED AND INCOMPLETE. THE STAPLE LINE WAS REINFORCED WITH SUTURE TO FIX THE ISSUE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 18428707 ↗
• MalfunctionJul 19, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN S6 RESECTION OF THE LEFT LOWER LOBE WITH RADICAL SINGLE-PORT THORACOSCOPIC PROCEDURE, THE STAPLER FIRED COMPLETELY BUT THE STAPLE LINE WAS DISTALLY INCOMPLETE. TO RESOLVE THE ISSUE, REINFORCEMENT SUTURING WAS DONE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17350584 ↗
• MalfunctionJun 6, 2023Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN THE 60 MILLIMETER TRI-STAPLE BLACK RELOAD WAS USED ON THE FIRST FIRING OF THE STAPLER ON THE STOMACH, THE SURGEON RECEIVED THE EXCESSIVE TISSUE ERROR. ANOTHER 60 MILLIMETER TRI-STAPLE BLACK RELOAD WAS USED AND ONCE AGAIN, VERY QUICKLY RECEIVED ANOTHER EXCESSIVE TISSUE ERROR. TROUBLE SHOOTING WAS PERFORMED AND THE STAPLER WOULD NOT FIRE. A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074503 ↗
• MalfunctionJun 6, 2023Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN THE 60 MILLIMETER TRI-STAPLE BLACK RELOAD WAS USED ON THE FIRST FIRING OF THE STAPLER ON THE STOMACH, THE SURGEON RECEIVED THE EXCESSIVE TISSUE ERROR. ANOTHER 60 MILLIMETER TRI-STAPLE BLACK RELOAD WAS USED AND ONCE AGAIN, VERY QUICKLY RECEIVED ANOTHER EXCESSIVE TISSUE ERROR. TROUBLE SHOOTING WAS PERFORMED AND THE STAPLER WOULD NOT FIRE. A NEW DEVICE FROM ANOTHER MANUFACTURER WAS USED TO FINISH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074395 ↗
• MalfunctionFeb 23, 2023Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, IN DISSOCIATING THE PANCREAS, THE SURGEON PRESSED THE GREEN BUTTON. HOWE VER, THE HANDLE COULD NOT BE SQUEEZE. THE DEVICE DID NOT FIRE. ADDITIONALLY, THE DEVICE COULD NOT BE UNLOAD. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433242 ↗
• MalfunctionSep 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDLE ALLOWED THE RELOAD TO BE ACTIVATED BY PRESSING THE GREEN BUTTON BUT IT DID NOT ADVANCE AND THE HANDLE CANNOT BE SQUEEZED. ANOTHER RELOAD WAS LOADED BUT SAME ISSUE OCCURRED. THE SURGEON THEN REPLACED THE HANDLE IN ORDER TO COMPLETE THE CASE.

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

  MAUDE report 15397369 ↗
• MalfunctionSep 9, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DISTAL PANCREATECTOMY, WHILE RESECTIONING THE DISTAL PANCREAS, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE EVEN WHEN THE GREEN BUTTON WAS PRESSED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15394340 ↗
• MalfunctionAug 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE 60 MM RELOAD BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15269406 ↗
• MalfunctionAug 19, 2022Entrapment of Device; Misfire; Difficult to Open or Close; Entrapment of Device; Misfire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, WHILE TRANSECTING STOMACH, JAWS WERE UNABLE TO OPEN. THE DEVICE WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15260789 ↗
• MalfunctionMay 5, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE WAS NOT SEALING OR CUTTING.

  Patient problems: Insufficient Information

  MAUDE report 14287001 ↗
• InjuryFeb 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LIFE THREATENING SERIOUS INJURY THAT RESULTED FROM USE OF THE DEVICE. TREATMENT INCLUDED INTENSIVE CARE TREATMENT, EXTENDED HOSPITALIZATION, AND SUBSEQUENT SURGERIES TO CORRECT THE INJURIES.

  Patient problems: Abdominal Distention; Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Dehydration; Diarrhea; Discomfort; Dysphagia/ Odynophagia; Dyspnea; Emotional Changes; Erythema; Fever; Fibrosis; Fluid Discharge; Heartburn/Indigestion; Hemorrhage/Blood Loss/Bleeding; Inflammation; Insufficient Information; Memory Loss/Impairment; Nausea; Nodule; Pain; Perforation; Purulent Discharge; Swollen Lymph Nodes/Glands; Vomiting; Wound Dehiscence

  MAUDE report 13418834 ↗
• MalfunctionDec 9, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC DISTAL PANCREATECTOMY, WHILE RESECTING THE PANCREAS, THE JAW OF THE REINFORCED RELOAD COULD NOT BE OPENED. THE DEVICE WAS REMOVED BY SHAKING THE HANDLE. ANOTHER RELOAD OF THE SAME TYPE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968729 ↗
• InjuryOct 28, 2021Misfire; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Misfire; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC SLEEVE, THE THIRD RELOAD STOPPED FIRING HALFWAY. STAPLE LINE WAS INCOMPLETE DISTALLY AD SOME STAPLES WERE NOT CLOSED SO RELOAD HAD TO BE REMOVED. ANOTHER RELOAD WITHOUT REINFORCEMENT MATERIAL WAS USED AND THE WHOLE STAPLE LINE WERE OVERSEWN. SIX DAYS AFTER THE SURGICAL PROCEDURE, THE PATIENT DEVELOPED A LEAK IN THE STOMACH. THIS LEAK WAS REPAIRED USING SUTURE.

  Patient problems: Failure to Anastomose

  MAUDE report 12715747 ↗
• InjuryOct 28, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, THE FIRST TWO RELOADS FIRED WITHOUT PROBLEMS ON THE STOMACH. THE THIRD RELOAD COULD ONLY BE FIRED HALFWAY AND THE STAPLE LINE WAS INCOMPLETE CENTRALLY. THE LAST PART OF THE RELOAD COULD NOT BE FIRED. THE STAPLES WERE NOT PROPERLY CLOSED AT THE END. THE RELOAD WAS ANGLED AT THE STOMACH. THE USER GOT ANOTHER RELOAD AND USED THE SAME HANDLE FOR THE STAPLE LINE TO BE SOWN OVER TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12715646 ↗
• MalfunctionOct 20, 2021Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE RESECTING THE STOMACH IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, FIRST RESECTION WORKS FINE WITH A REINFORCED PURPLE RELOAD. THE SECOND RESECTION WAS PREVENTED BY THE POWERED HANDLE WITH REINFORCED PURPLE RELOAD. THE STAPLE LINE WAS ALSO PROXIMALLY INCOMPLETE. THE SURGEON CHOSE A REINFORCED BLACK RELOAD HOWEVER THE STAPLER STILL PREVENT IT FROM FIRING. TO RESOLVE THE ISSUE, A NEW BLACK RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12667354 ↗
• MalfunctionOct 13, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD WAS NOT ABLE TO FIRE.

  Patient problems: Insufficient Information

  MAUDE report 12627856 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE PATIENT HAD LEAKAGE AT THE FUNDUS OF THE STOMACH. THE PATIENT HAD TISSUE DAMAGE AND STILL AT THE ICU (INTENSIVE CARE UNIT) FOR ABOUT A WEEK.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12578771 ↗
• MalfunctionAug 5, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPY-ASSISTED LOBECTOMY, ON INTERLOBAR RESECTION, WHEN THE REPORTED PRODUCT WAS RELOADED AND USED IN THE POWERED HANDLE, THE FIRING OF THREE COLLECTED CARTRIDGES COULD NOT BE PERFORMED UNTIL THE END, THE STAPLE LINE WAS INCOMPLETE CENTRALLY, THE STAPLER FIRED BUT STOPPED HALFWAY THROUGH THE FIRING PROCESS. FIRING OF OTHER THAN THE APPLICABLE THREE CARTRIDGES COULD BE PERFORMED. THE HANDLE, SHELL, ADAPTER AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283156 ↗
• MalfunctionAug 4, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING TRANSECTION OF STOMACH IN A SLEEVE GASTRECTOMY, THERE WAS INCOMPLETE STAPLE LINE DISTALLY. STAPLE FORMATION IS NORMAL, HOWEVER UNABLE TO ADVANCE FIRING TILL THE END. SURGEON REPLACED THE DEVICE TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278612 ↗
• MalfunctionAug 2, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THERE WAS PROBLEM LOADING THE ADAPTOR ONTO THE HANDLE. THE CHARGER HAS NOT BEEN RECOGNIZED BY THE HANDLE. IT WAS ALSO NOTED THAT THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE DEVICE DID NOT FIRE. THE SURGEON HAD TO TAKE ANOTHER RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12264128 ↗
• MalfunctionJun 24, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PANCREATIC RESECTION ON A LAPAROSCOPIC DISTAL PANCREATECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE HANDLE WAS NOT SQUEEZED. THE STAPLER DID NOT FIRE. A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12057152 ↗
• MalfunctionJun 10, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, BEFORE FULL FIRING TO THE END OF THE PANCREAS DURING A LAPAROSCOPIC DISTAL PANCREATECTOMY, THE BLACK RETURN KNOB WAS PULLED BACK A LITTLE, AND FOUND THAT IT WAS NOT FIRED TO THE END, AND THEN FIRED AGAIN. EVEN THOUGH THERE WAS AN ABNORMAL SOUND LIKE PLASTIC CRACKING HEARD FROM THE HANDLE, IT STILL FIRED TO THE END. THE BLACK RETURN KNOB WAS COMPLETELY PULLED BACK AFTER FIRING, BUT THE TIP OF THE RELOAD DID NOT OPEN. THE TISSUE INSIDE THE RELOAD SEEMED TO HAVE BEEN FIRED AND RESECTED NORMALLY, AFTER A WHILE, THE TISSUE FELL OUT OF THE RELOAD, AND EVEN THOUGH THE TIP OF THE RELOAD COULD NOT BE OPENED, BUT IT COULD BE RELEASED FROM THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979927 ↗