Endo GIA EGIATRS45AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10884521190887), received between Feb 17, 2017 and May 14, 2024 — classified as 7 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (20 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 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2024Material Rupture; Failure to Form Staple; Material Rupture; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC BARIATRIC PROCEDURE, WHEN FIRING THE STAPLER IN THE STOMACH, THE REINFORCEMENT SHEET OF TWO RELOADS TORE DURING STAPLING. THERE WAS POOR STAPLE FORMATION. IT WAS NECESSARY TO USE ADDITIONAL RELOADS TO RESOLVE THE POOR STAPLE FORMATION.

  Patient problems: Tissue Breakdown

  MAUDE report 19312460 ↗
• MalfunctionOct 25, 2022Entrapment of Device; Retraction Problem; Failure to Form Staple; Entrapment of Device; Retraction Problem; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WEDGE RESECTION PROCEDURE, WHEN DISSECTION OF THE MODULE, TWO ROWS FIRED THEN THE DEVICE BLADE WAS UNABLE TO RETRACT. THE STAPLE LINE WAS INCOMPLETE PROXIMALLY. THE JAWS OF THE DEVICE LOCKED ON TISSUE. THE SURGEON WIGGLED THE DEVICE AND WAS UNLOCKED ON THE TISSUE. TO RESOLVE THE ISSUE, THE SURGEON OPENED A NEW STAPLER IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667951 ↗
• MalfunctionOct 18, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, WHEN USED ON LUNG TISSUE, THE DEVICE WAS UNABLE TO FIRE - GREEN BUTTON WAS PRESSED BUT HANDLE COULD NOT BE SQUEEZED. THE USER TRIED TO REATTACH THE RELOAD AND PRESSED THE GREEN BUTTON BUT HANDLE COULD STILL NOT BE SQUEEZED. ANOTHER HANDLE AND RELOAD WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15621538 ↗
• MalfunctionFeb 11, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC GASTRECTOMY, DURING THE RESECTION OF THE LAST PORTION OF THE STOMACH, THE RELOAD WAS LOCKED FROM THE START AND COULD NOT BE FIRED. ANOTHER RELOAD AND THE SAME HANDLE WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314598 ↗
• MalfunctionDec 17, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN STAPLING DURING A LAPAROSCOPIC LOBECTOMY, THE STAPLER DID NOT FIRE. THE STAPLE WAS FIXED WITH ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9485458 ↗
• MalfunctionDec 6, 2019Difficult to Remove; Failure to Fire; Difficult to Remove; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LUNG RESECTION PROCEDURE, ON THE SECOND FIRING, AFTER THE DEVICE HANDLE WAS SQUEEZED, THE GREEN BUTTON WAS PRESSED AND FIRING WAS ATTEMPTED ON THE THICK LUNG PARENCHYMA BUT THE JAWS OPENED AND THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED AND FIRING WAS PERFORMED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9433788 ↗
• MalfunctionDec 5, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING WEDGE/SEGMENTAL RESECTION, IT WAS NOTED THAT THE LOCK RING HAS CRACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9416280 ↗
• MalfunctionOct 23, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE FIRST APPLICATION IN GASTRIC ¿ANTRUM¿ ON A LAPAROSCOPIC GASTRIC SLEEVE, AFTER LOADING THE RELOAD, THE SURGEON WAS ABLE TO SQUEEZED THE HANDLE BUT THE STAPLER DID NOT FIRE. ANOTHER THREE HANDLES AND NINE RELOADS WERE OPENED BUT SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NEW HANDLE AND RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226360 ↗
• MalfunctionSep 26, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC BULLECTOMY OF RIGHT LUNG VIDEO-ASSISTED THORACOSCOPIC SURGERY, AFTER FIRING THE LUNG, THE JAWS OF THE RELOAD COULD NOT OPEN. IT WAS FOUND OUT THAT THE BEAM WAS NOT FULLY RETRACTED. ANOTHER INSTRUMENT WAS USED TO OPEN THE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: Chills

  MAUDE report 9126758 ↗
• MalfunctionJul 25, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER DURING A WEDGE RESECTION OF THE LUNG, THE FIRST AND THE SECOND FIRING WERE COMPLETED WITH NO PROBLEM. FOR THE THIRD FIRING (THE ADDITIONAL RESECTION),THEY SET THE DEVICE WITH NO PROBLEM. THE SURGEON STARTED THE FIRING AND THE SURGEON FELT THAT IT ADVANCED SLIGHTLY, BUT IT STOPPED AND COULD NOT ADVANCE ANY MORE. THEY RE-CONNECTED THE CARTRIDGE AND CHECKED THE JAWS OPENING/CLOSING, AND THE SURGEON TRIED TO FIRE THE DEVICE, BUT THE SAME EVENT OCCURRED AND COULD NOT FIRE THE DEVICE. REPLACED BY NEW CARTRIDGE AND SET THE DEVICE, AND THE FIRING WAS COMPLETED WITH NO PROBLEM. THE SAME HANDLE WAS USED THROUGH OUT THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829411 ↗
• MalfunctionJul 25, 2019Difficult or Delayed Positioning; Misfire; Failure to Form Staple; Difficult or Delayed Positioning; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER DURING GASTRIC BAND REMOVAL FOLLOWED BY GASTROPLASTY, WHEN THE DEVICE WAS BEING USED IN THE STOMACH, AT THE MOMENT OF THE FIRING OF BOTH DEVICE, THERE WAS RESISTANCE IN THE STRUCTURE OF THE STOMACH INTERRUPTING THE FIRING THEREFORE AN INCOMPLETE FIRING. BOTH DEVICE HAVE THEIR STAPLE LINE INCOMPLETE IN THE DISTAL END. THE STAPLES WERE ALSO NOT ABLE TO FORM A B-SHAPE. ANOTHER RELOAD WAS USED WITH THE SAME HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829335 ↗
• MalfunctionJul 22, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THORACO/LOBECTOMY, THE FIFTH FIRING STOPPED WHEN RESECTING THE BRONCHUS. WHEN THE SCREEN WAS CHECKED, THE SCREEN WAS DARK AND AS IT WAS UNCLEAR WHAT WAS DISPLAYED, THERE WAS NO EXCESSIVE FORCE INDICATOR. IT WAS NOTED THAT THE JAWS ROOT CLAMPED WITHOUT PROBLEM WHEN CHECKED BY THORACOSCOPE CAMERA. A NEW RELOAD WAS OPENED AND THE FIRING WAS COMPLETED. THE EXTENDED SURGERY TIME WAS ABOUT 5 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813480 ↗
• MalfunctionMar 19, 2019Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY BULLECTOMY, WHEN IT WAS BEING APPLIED TO THE LUNG TO TAKE THE BULLA OUT, WHEN THEY STARTED TO FIRE, THERE WAS A LOUD CRACK AND THEY WERE NOT ABLE TO COMPRESS IT AGAIN. THE STAPLE LINE WAS INCOMPLETE DISTALLY. THEY OPENED A SECOND HANDLE AND THE SAME THING HAPPENED WITH THE THREE RELOADS AND THEN WITH THE OTHER TWO TYPES OF RELOADS AS WELL. THEY OPENED ANOTHER STAPLER AND WAS FIRED AT A DIFFERENT ANGLE TO THE EXISTING FIRINGS AND IT WORKED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432234 ↗
• MalfunctionFeb 27, 2019Break; Unintended Movement; Break; Unintended Movement

  ACCORDING TO THE REPORTER: DURING A GASTRIC SLEEVE PROCEDURE, THE HANDLE WAS PREPARED FOR USE. WHEN AN ATTEMPT WAS MADE TO OPEN THE JAWS AS PART OF THE PREPARATION AND BEFORE USE ON THE PATIENT, THERE WAS AN ABNORMAL SURGING SOUND. THE KNIFE ADVANCED AND PROTRUDED THOUGH THE ARTICULATION JOINT, AND THE RELOAD ARTICULATED 45 DEGREES. WHEN ATTEMPTING TO STRAIGHTEN, OPEN, AND REMOVE THE RELOAD, THE RELOAD BECAME PARTIALLY DISCONNECTED FROM THE ADAPTER. THE RELOAD COULD NOT BE FULLY REMOVED FROM THE ADAPTER. THE RELOAD AND ADAPTER WERE THEN REMOVED TOGETHER FROM THE HANDLE. A SECOND ADAPTER WAS PLACED ON THE HANDLE, BUT A RELOAD COULD NOT BE CONNECTED. THE FIRING ROD IN THE ADAPTER APPEARED TO BE PROTRUDING. THE PATIENT WAS NOT INVOLVED AT THE TIME THIS INCIDENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NEW SHELL AND A NEW RELOAD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8376066 ↗
• InjuryJan 18, 2019Entrapment of Device; Misfire; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION, AT THE SECOND FIRING, THE STAPLING STOPPED MIDWAY THROUGH THE FIRING. IT WAS STATED THAT THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. ADDITIONAL TISSUE RESECTION WAS REQUIRED DUE TO THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MIN.

  Patient problems: No Code Available

  MAUDE report 8261260 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTROPLASTY, WHILE ON STOMACH - POUCH, THE DOCTOR REPORTED THAT EVEN WITH THE LOAD-BEARING FILM THE CLAMP LINE BLED. THE DOCTOR NEEDED TO OVERSEW THE CLAMP LINE TO RESOLVE THE ISSUE.

  Patient problems: No Code Available

  MAUDE report 8256321 ↗
• MalfunctionNov 8, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN WEDGE SEGMENTAL RESECTION, ON THE FIRST FIRING, WHEN THE SURGEON TRIED TO FIRE THE DEVICE IT WAS TO STIFF AND THE DEVICE COULD NOT BE FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8051033 ↗
• InjuryNov 5, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING OF A WEDGE SEGMENTAL RESECTION PROCEDURE, THE REINFORCED RELOAD COULD BE USED NORMALLY, BUT AT THE SECOND FIRING, THERE WAS A CRACK SOUND AND THE DEVICE COULD ONLY FIRE UNTIL HALFWAY. OOZING BLEEDING OCCURRED AS A RESULT OF THE ISSUE. ALTHOUGH THE HANDLE AND THE RELOAD WERE REPLACED MANY TIMES, THE SAME EVENT OCCURRED, SO FINALLY THE SUTURE WAS COMPLETED BY HAND.

  Patient problems: No Code Available

  MAUDE report 8037534 ↗
• MalfunctionAug 27, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS PUT IN THE PATIENT¿S CAVITY DURING A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY, THE JAW DID NOT OPEN, ALTHOUGH THE BUTTON WAS PRESSED MANY TIMES, IT DID NOT OPEN. THE DOCTOR APPEALED THAT ALL THE BUTTONS DID NOT WORK AT THAT MOMENT. THE CARTRIDGE WAS REPLACED WITH A NEW ONE. AFTER THAT, THE DEVICE COULD BE USED WITHOUT PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7818304 ↗
• MalfunctionJul 24, 2018Failure to Fire; Firing Problem; Failure to Fire

  ACCORDING TO THE REPORTER: AT THE SECOND FIRING OF LAPAROSCOPIC LOWER ANTERIOR RESECTION OR RECTUM RESECTION, THE SURGEON COULD NOT FIRE THE DEVICE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND PUSHED THE CENTER CONTROL BUTTON, HOWEVER THE FIRING WAS NOT PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715116 ↗
• MalfunctionJul 17, 2018Failure to Fire; Firing Problem; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE FIRST FIRING OF SEGMENTAL RESECTION OF LUNG, AFTER THEY CONNECTED THE RELOAD TO THE HANDLE, THE SURGEON TRIED TO FIRE THE DEVICE BUT THEY COULD NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7694034 ↗
• MalfunctionJun 15, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE FOURTH FIRING OF A LOBECTOMY PROCEDURE, THE SURGEON RESECTED PULMONARY PARENCHYMA WITH NON-ART INCULCATED RELOAD, HOWEVER, DUE TO EXCESSIVE FORCE, HE COULD NOT STAPLE THE TISSUE TO THE DISTAL END. HE FELT THE TISSUE WAS NOT THAT THICK. THEY TRIED TO SQUEEZE THE HANDLE AGAIN BUT THEY COULD NOT FIRE THE DEVICE ANYMORE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606753 ↗
• MalfunctionJun 15, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: DURING PNEUMOTHORAX, A YELLOW FOREIGN MATERIAL FELL INTO THE CAVITY BUT IT WAS RETRIEVED. THE SURGEON NOTICED YELLOW SHIPPING WEDGE OF THE RELOAD WAS BROKEN. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. NO PATIENT INJURY. AS THE SURGEON COULD NOT IDENTIFY OF WHICH RELOAD THE YELLOW FOREIGN MATERIAL HAD BELONG, THE SURGEON REPORTED 2 RELOADS. AFTER THE SURGERY, THE SALES REP SPOKE WITH THE CUSTOMER AND CONFIRMED THIS EVENT CAUSED BY A NEW NURSE'S DEVICE HANDLING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7606603 ↗
• InjuryMay 15, 2018Entrapment of Device; Difficult to Open or Close; Entrapment of Device; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LOW ANTERIOR RESECTION, THE SURGEON FULLY FIRED THE DEVICE, HOWEVER THEY COULD NOT PULL THE BLACK RETURN KNOB BACK TO THE INITIAL POSITION AND COULD NOT OPEN THE JAWS. THE SURGEON ADDITIONALLY RESECTED THE TISSUES OF THE MOUTH SIDE AND ANUS SIDE, AND REMOVED THE CARTRIDGE FROM THE TISSUE, THEN SUTURED THE RESECTED PART MANUALLY. THE SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. THE INCISION SITE WAS NOT EXTENDED. NOTHING FELL INTO THE PATIENT'S CAVITY. NO BLEEDING OCCURRED.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7516299 ↗
• MalfunctionApr 30, 2018Separation Failure; Separation Failure

  ACCORDING TO THE REPORTER: OCCURRED DURING A COLECTOMY FUNCTIONAL END TO END ANASTOMOSIS PROCEDURE. FOR THE SECOND FIRING, AT THE CLOSURE OF THE INSERTION, THE SURGEON FULLY SQUEEZED THE HANDLE. HOWEVER, THE ANCHORING SUTURE AT THE TIP WAS NOT REMOVED. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7473561 ↗