Endo GIA EGIATRS60AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 274 adverse event reports that list this exact device (DI 10884521191013), received between Feb 18, 2016 and Oct 30, 2024 — classified as 2 deaths, 30 injuries, 242 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (122 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 274 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A THORACIC PROCEDURE, WHILE STAPLING THE PULMONARY PARENCHYMA, THE STAPLES WERE JAWED AND HAD POOR FORMATION. THIS RESULTED IN PULMONARY PARENCHYMAL BLEEDING AND NO AERO STASIS (AIR LEAK). TO RESOLVE THE ISSUE, THE HANDLE WAS CHANGED AND A NEW RELOAD FROM A DIFFERENT LOT NUMBER WAS USED. ADDITIONALLY, METAL CLIPS WERE PLACED.

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

  MAUDE report 20571388 ↗
• MalfunctionJun 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO PLEUROSCOPY, DURING PLEURA CLIPPING, AFTER THE SURGEON PUSHED THE GREEN BUTTON AND WENT TO ACTIVATE, THE TRIGGER HANDLE MADE A SOUNDING NOISE, AS IF THE STAPLER WAS GOING TO BREAK, AND THE CHARGE THAT WAS IN THE STAPLER DID NOT FIRE, NO LONGER PERFORMING THE CLIPPING. A NEW STAPLER AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19520929 ↗
• MalfunctionJan 19, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN SUBTOTAL GASTRECTOMY PROCEDURE, ON THE STOMACH, AFTER THE RELOAD WAS LOADED TO THE HANDLE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. HOWEVER, THE DEVICE DID NOT FIRE AND MADE A STRANGE NOISE, AS IF SOMETHING HAD BROKEN. TO RESOLVE THE ISSUE, A POWERED HANDLE WAS USED WITH A NEW RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541632 ↗
• MalfunctionOct 26, 2023Unintended System Motion; Device Difficult to Setup or Prepare; Unintended System Motion; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC DISTAL PANCREATECTOMY PROCEDURE, AT THE TIME OF TRANSECTING THE PANCREAS, THE RELOAD WAS ARTICULATED TO ALMOST 45 DEGREE TO THE LEFT AND IT AUTOMATICALLY ARTICULATED BACK TO ITS NEUTRAL POSITION WHEN THE SURGEON WAS RETRIEVING THE KNIFE. THIS LED TO THE PANCREAS BEING TORN A BIT. IT WAS NOTED THAT BEFORE FIRING, A "CRACK" SOUND WAS HEARD BUT THE DEVICE WAS STILL ABLE TO FIRE IN ZONE 1 POSITION. THE SURGEON USED TISSEEL, HEMOPATCH, AND SUTURE TO FIX THE TORN PANCREAS. AFTER THE PROCEDURE, IT WAS FOUND OUT THAT THE RELOAD WAS NOT IN ITS PROPER POSITION WHEN IT WAS ARTICULATED.

  Patient problems: Tissue Breakdown

  MAUDE report 18012145 ↗
• InjurySep 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REVIEW OF SECONDARY DATA SOURCES OF A STUDY ABOUT THE EFFECTIVENESS OF BEDSIDE STAPLERS (BS) COMPARED WITH ROBOTIC STAPLERS (RS) IN BARIATRIC ROBOTIC PROCEDURES INVOLVING 7268 DISCHARGES, PERFORMED BETWEEN (B)(6) 2021, THE FOLLOWING CLINICAL OUTCOME WAS OBSERVED USING 60MM ARTICULATING ENDOSCOPIC REINFORCED STAPLING RELOAD: BLEEDING IN ONE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17830321 ↗
• MalfunctionAug 25, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, READY TO FIRE, SURGEON WAS ABLE TO PRESS THE GREEN, BUT COULD NOT SQUEEZE THE HANDLE AND THE STAPLER DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627083 ↗
• InjuryJan 26, 2023Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AT THE TIME OF LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, IT WAS NOTED THAT THE PURPLE REINFORCED RELOAD WAS USED IN GASTROJEJUNOSTOMY. FUNCTIONAL END TO END (FEE) ANASTOMOSIS WAS DONE WITH ANOTHER TYPE OF REINFORCED PURPLE RELOAD FOR CLOSURE OF THE INSERTION HOLE. THE NEXT DAY AFTER, THE EDGE OF THE REINFORCED SHEET WAS OPEN LIKE IT WAS TORN APART FROM A MAJOR LEAK IN THE GASTRO-JEJUNAL FEE ANASTOMOSIS. DUE TO THE MAJOR LEAK, THERE WAS TISSUE DAMAGE, EXTENDED INCISION AS THE PATIENT HAD REOPERATION WITH REANASTOMOSIS.

  Patient problems: Failure to Anastomose; Unspecified Tissue Injury

  MAUDE report 16249464 ↗
• MalfunctionNov 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE IN THE STOMACH, THE CENTRAL PART OF THE STAPLE LINE DID NOT FORM WELL OVER THE TISSUE AND FELL OFF. THE STAPLE LINE WAS BLEEDING OR OOZING AND THE SURGEON HAD TO OVER-STITCH THE AFFECTED PART. THE SURGICAL TIME WAS EXTENDED BY 20 MINUTES. PLI 40- MEDTRONIC'S INITIAL EVALUATION OF THE RETURNED PRODUCT FOUND THE RELOAD INTERLOCK WAS TESTED AND WAS FOUND TO FUNCTION PROPERLY.

  Patient problems: Insufficient Information

  MAUDE report 15790905 ↗
• MalfunctionAug 29, 2022Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BARIATRIC PROCEDURE, IN THE STOMACH, THE FIRST DEVICE HAD A TRIGGERING DIFFICULTY. AFTER THAT, THE SECOND RELOAD HAD A POOR STAPLE FORMATION AND WAS NOT ABLE TO FIRE COMPLETELY. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WITHOUT REINFORCEMENT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316710 ↗
• MalfunctionAug 24, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRIC MINI BYPASS, WHEN STAPLING THE STOMACH, THE STAPLER DID NOT FIRE. THE SURGEON WAS BALE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE INSTRUMENT WAS CHANGED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287385 ↗
• MalfunctionAug 16, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A OPEN PROCEDURE, WHEN STAPLING THE PANCREAS, THE LOAD DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237526 ↗
• DeathJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC PANCREATECTOMY PROCEDURE, FOR THE PANCREAS (FLOW BODY), AN EMERGENCY LAPAROTOMY WAS DONE TO THE PATIENT AFTER A MONTH FROM SURGERY. THE SURGEON CLAIMED THE ENTIRE PROCEDURE WAS FOLLOWED, THAT EVERYTHING HAPPENED NORMAL WITHOUT ANY TYPE OF COMPLICATIONS. THE PATIENT DIED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15098464 ↗
• MalfunctionJul 20, 2022Mechanical Problem; Failure to Form Staple; Mechanical Problem; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC BARIATRIC PROCEDURE, WHEN THE SURGEON CUT THE TISSUE, THE STAPLER FIRED BUT THE RELOADS COULD NOT BITE THE TISSUE WELL. THERE WAS ALSO AN INCOMPLETE STAPLE LINE CENTRALLY. 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 15066164 ↗
• MalfunctionJul 20, 2022Mechanical Problem; Failure to Form Staple; Mechanical Problem; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC BARIATRIC PROCEDURE, WHEN THE SURGEON CUT THE TISSUE, THE STAPLER FIRED BUT THE RELOADS COULD NOT BITE THE TISSUE WELL. THERE WAS ALSO AN INCOMPLETE STAPLE LINE CENTRALLY. 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 15066103 ↗
• MalfunctionJul 15, 2022Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE VIDEO ASSISTED THORACOSCOPIC LOBECTOMY SURGERY, AT THE TIME OF STAPLING THE LUNGS, THE SURGEON INSERTED THE STAPLER INTO THE CAVITY BUT THE RELOAD COULD NOT BE OPENED TO PERFORM THE STAPLING. IT WAS ALSO REPORTED THAT THE STEM BROKE OFF. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032769 ↗
• InjuryJun 30, 2022Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, WHILE USING THE DEVICE ON THE LUNG DURING AN OPEN BULLECTOMY, SURGEON STATES THAT AT THE TIME OF FIRING, IT STAPLE RIGHT SIDE OF REINFORCEMENT BUT NOT ON TISSUE AND LEFT SIDE HAD NO STAPLES AND REINFORCEMENT LOOSE. IT WAS NOTED THAT THERE WAS INCOMPLETE STAPLE LINE CENTRALLY. TISSUE WAS PARTIALLY DAMAGED DUE TO PRESSURE OF THE JAWS OF THE DEVICE AND SINCE THERE WERE NO STAPLES ON THE LEFT SIDE OF THE STAPLE LINE, IT RESULTED WITH LOSS OF BLOOD. BLOOD LOSS WAS 500CC OR MORE THAT REQUIRE A BLOOD TRANSFUSION. SURGEON HAD TO CONTROL BLOOD LOSS AND SUTURE THE TISSUE THAT DID NOT HAD STAPLES. PATIENT HAD TO BE BACK IN SURGERY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 14880652 ↗
• MalfunctionJun 21, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC BARIATRIC PROCEDURE, DURING THE SECOND FIRING. 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

  MAUDE report 14759898 ↗
• MalfunctionJun 8, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING SECOND FIRING WITH PURPLE RELOADS WITH REINFORCEMENT IN A LAPAROSCOPIC BARIATRIC, THE SURGEON MADE A PRE-SHOT MAKING THE SHOOTING NOISE, MADE THE READING AS IF IT HAD STAPLED, BUT MADE ONLY A PRE-SHOT LOCKING THE LOAD. IT WAS REPLACED BY A LOAD WITHOUT REINFORCEMENT AND THE STAPLING WAS DONE IN THE CORRECT WAY. SURGEON REPORTED THREE DEFECTIVE RELOADS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634536 ↗
• MalfunctionJun 3, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING SECOND FIRING WITH PURPLE RELOADS AND REINFORCEMENT IN A LAPAROSCOPIC BARIATRIC PROCEDURE, THE SURGEON MADE A PRE-SHOT MAKING THE SHOOTING NOISE. IT MADE THE READING AS IF IT HAD STAPLED, BUT MADE ONLY A PRE-SHOT LOCKING THE LOAD. IT WAS REPLACED BY A LOAD WITHOUT REINFORCEMENT AND THE STAPLING WAS DONE IN THE CORRECT WAY. THE SURGEON REPORTED THREE DEFECTIVE RELOADS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14597253 ↗
• MalfunctionJun 3, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING SECOND FIRING WITH PURPLE RELOADS WITH REINFORCEMENT IN A LAPAROSCOPIC BARIATRIC, SURGEON MADE A PRE-SHOT MAKING THE SHOOTING NOISE, MADE THE READING AS IF IT HAD STAPLED, BUT MADE ONLY A PRE-SHOT LOCKING THE LOAD, WAS REPLACED BY A LOAD WITHOUT REINFORCEMENT AND THE STAPLING WAS DONE IN THE CORRECT WAY. SURGEON REPORTED 3 DEFECTIVE RELOADS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594868 ↗
• MalfunctionMay 11, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC GASTROINTESTINAL STROMAL TUMORS PROCEDURE, WHILE TRANSECTING THE GASTRIC, AND WHEN THE SURGEON TRIED TO DO A DOUBLE STAPLING ON TOP OF THE STAPLE LINE, THE DEVICE FAILED TO FIRE. EVEN AFTER CHANGING TO ANOTHER RELOAD, THE ISSUE STILL OCCURRED. THE SURGEON DID HAND SUTURING TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14350740 ↗
• MalfunctionApr 27, 2022Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, IN THE TRANSECTION OF GASTRIC TISSUE, TWO RELOADS DID NOT FIRE. THE SURGEON COULD PRESSED THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZED THE HANDLE. TO RESOLVE THE ISSUE, A NEW RELOAD AND HANDLE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14221055 ↗
• MalfunctionApr 12, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING ROBOTIC LAPAROSCOPIC LUNG SEGMENTECTOMY, THE RELOAD WAS NOT ABLE TO FIRE UNTIL THE END. THERE WAS INCOMPLETE STAPLE LINE DISTALLY. SURGEON REPLACED THE RELOAD TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087122 ↗
• MalfunctionApr 12, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, WHEN THE DEVICE TRIED TO BE FIRED, IT FAILED.

  Patient problems: Insufficient Information

  MAUDE report 14086764 ↗
• MalfunctionMar 24, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE, WHILE TRANSECTING THE GASTRIC TISSUE, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE, AND THE DEVICE DID NOT FIRE. THE RELOAD AND HANDLE WERE REPLACED TO COMPLETE THE SURGERY AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871538 ↗