Endo GIA EGIAADAPTRecalls & reported problems

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 10884521142800), received between Jul 1, 2016 and Sep 2, 2022 — classified as 15 injuries, 193 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 208 reports, in the reporter's own words as published by the FDA.

• InjurySep 2, 2022Entrapment of Device; Failure to Calibrate; Misfire; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Calibrate; Misfire; Human-Device Interface Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, IN THE MIDDLE OF A RECTAL RESECTION AFTER FINISHING THE DETACHMENT AROUND THE RECTUM, THE DEVICE PARTIALLY FIRED AND THE JAWS COULD NOT BE OPENED. THE HANDLE AND BATTERY WERE REPLACED, BUT THE CALIBRATION DID NOT GO WELL. A MANUAL ADAPTER TOOL WAS USED, BUT THE JAWS WOULD STILL NOT NOT OPEN AND THE KNIFE DID NOT RETURN. IT WAS ALSO NOTED THAT THE ARTICULATION PART OF CARTRIDGE WAS DAMAGED AND A COMPONENT FELL INTO THE PATIENT'S CAVITY. THE RELOAD REMAINED ARTICULATED, THUS THE RELOAD COULD NOT BE REMOVED FORM THE ADAPTER AND COULD NOT BE REMOVED FROM THE TROCAR. THE INVOLVED TROCAR WAS USED WITHOUT ANY MALFUNCTION. THE SURGEON CONVERTED THE SURGERY INTO AN OPEN SURGERY, EXTENDED THE INCISION FOR MORE THAN 1 INCH, USED FORCEPS TO CLAMP AND TAKE OUT THE COMPONENT AND CUT CLOSER TO THE ANUS USING A MANUAL HANDLE TO REMOVE THE DEVICE. A CIRCULAR STAPLING DEVICE WAS THEN USED TO COMPLETE THE ANASTOMOSIS. THIS LED TO TISSUE LOSS AND OVER 30 MINUTES EXTENDED SURGICAL TIME.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15350614 ↗
• MalfunctionNov 29, 2021Misfire; Component or Accessory Incompatibility; Misfire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER DURING AN OPEN DISTAL GASTRECTOMY PROCEDURE, WHEN RESECTING THE STOMACH, FIRING WAS PERFORMED BUT IT STOPPED MIDWAY, COMPRESSION WAS ADVANCED, BUT IT DID NOT ADVANCE. IT WAS ALSO REPORTED THAT THE JAWS OF THE DEVICE LOCKED ON TISSUE. THERE WAS ALSO A TIME THAT LOADING THE CARTRIDGE TO THE ADAPTER WAS NOT POSSIBLE. TO FIX THE ISSUE, THE JAWS WERE REMOVED USING A MANUAL ADAPTER TOOL AND THE FIRING WAS PERFORMED TO FIX THE STAPLE LINE. THE BATTERY WAS ALSO REINSERTED AND RELOADED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12881811 ↗
• MalfunctionOct 6, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC PARTIAL COLLECTION, THE FIRING WAS NOT FINISHED. SURGEON REPLACED THE DEVICE WITH A MANUAL STAPLER. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584963 ↗
• MalfunctionAug 9, 2021Failure to Fire; Human-Device Interface Problem; Failure to Fire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SIGMOIDECTOMY, AFTER THE DEVICE WAS ASSEMBLED, AND WHEN ENTERED I THE CAVITY IT SEEMED THAT IT WAS SOFT. THE ACCOUNT THEN TURNED ON AND IT DIDN'T COMPLY ALL THE COMMANDS AND DIDN'T RELEASE THE STAPLE. WHEN IT WAS DONE THE ATTEMPT TO CHANGE THE RELOAD WAS ALSO MADE, BUT IT DIDN'T OPEN AND CRASHED. THE ACCOUNT TRIED A LOT TO GET THE RELOAD, BUT IT BROKE IN THE STAPLE. THE SURGEON THEN USED ANOTHER DEVICE 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 12293982 ↗
• MalfunctionJul 22, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, 3 CARTRIDGES COULD BE USED NORMALLY, THE FOURTH ONE WAS CONNECTED TO THE ADAPTER AND TISSUE WAS CLAMPED, BUT AFTER THAT FIRING COULD NOT BE PERFORMED. IT COULD BE RELEASED FROM THE TISSUE, AND WHEN LOOKING AT THE HANDLE, IT ILLUMINATED IN A WAY SIMILAR TO THE ONE IN WHICH OF THE ADAPTER END OF LIFE, BUT IT WAS UNCERTAIN WHETHER IT REALLY ILLUMINATED IN THAT WAY. ANOTHER TYPE OF POWERED HANDLE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214650 ↗
• MalfunctionJun 11, 2021Device Displays Incorrect Message; Failure to Fire; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, THE POWERED STAPLER WAS SET AND INSERTED THE INTESTINAL TRACT INTO THE JAWS OF THE REPORTED PRODUCT CARTRIDGE, THEN CLOSED THE JAWS, AND PRESSED THE GREEN BUTTON AND THE BLUE PUSH BUTTON, BUT THE SITUATION THAT THE STAPLING DID NOT ADVANCE WAS FOUND. IT WAS ALSO NOTED THAT THE STATUS INDICATOR ILLUMINATED IN BLUE IMMEDIATELY AFTER ATTACHMENT OF THE ADAPTER. THEREFORE, IN THAT CASE, THE POWERED STAPLER WAS STOPPED TO BE USED AND THE MANUAL HANDLE IN THE HOSPITAL WAS USED TO COMPLETED THE CASE. AT A LATER DATE, INSERTED THE BATTERY INTO THE POWERED HANDLE AND ATTACHED THE ADAPTER, BUT THE INDICATOR LAMP ABNORMALITY WAS FOUND. THE TROUBLE IN THE FIRST CASE AFTER REPLACING THE HANDLE AND THE ADAPTER WAS FOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11980897 ↗
• InjuryMay 4, 2021Entrapment of Device; Insufficient Device Problem Information; Entrapment of Device; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RESECTION, WHILE STAPLING THE DISTAL RECTUM, THE STAPLER WAS FIRED BUT HAD AN INCOMPLETE STAPLE LINE ON THE PROXIMAL PART. THERE WAS ALSO POOR STAPLE FORMATION. AS A RESULT, THE RECTAL WAS OPENED AND CAUSED PELVIC CONTAMINATION. IN ADDITION, THE DEVICE JAWS LOCKED ON TISSUE AND WERE REMOVED BY PRESSING THE GREY BUTTON UNTIL THE JAWS OPENED. THE SURGERY WAS CONVERTED TO OPEN. MORE RELOADS AND A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS TISSUE DAMAGE AS A RESULT OF THE EVENT. SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE AS A RESULT OF THE EVENT. PATIENT HOSPITALIZATION WAS EXTENDED FOR ONE WEEK. THE PATIENT PROGRESSED TO DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Sepsis; Unspecified Tissue Injury

  MAUDE report 11772250 ↗
• InjuryFeb 9, 2021Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LOW ANTERIOR RESECTION, UPON COLON RESECTION, THERE WAS POOR STAPLE FORMATION. STAPLER WAS NOT ABLE TO FIRE ALL STAPLES COMPLETELY THAT THE STAPLE LINE WAS INCOMPLETE IN PROXIMAL. ANOTHER COMPETITIVE STAPLER WAS USED FOR RESECTION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11300126 ↗
• InjuryJul 2, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, WHEN CUTTING THE COLON DURING LAPAROSCOPIC RIGHT HEMICOLECTOMY, THE RELOAD GOT STUCK ON THE COLON AND WOULD NOT OPEN. IT TOOK TIME TO TAKE THE RELOAD OUT. THE SURGEON INSERTED ANOTHER HANDLE AND CUT THE PART OF THE RELOAD THAT GOT STUCK ON THE COLON. THE EVENT RESULTED TO AN UNANTICIPATED TISSUE LOSS AND SURGICAL TIME EXTENDED TO 30 MINUTES. THE INCISION WAS ALSO EXTENDED.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 10227457 ↗
• MalfunctionApr 3, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, THE EVENT OCCURRED DURING THE FIRST FIRING OF A LAPAROSCOPIC LOW ANTERIOR RESECTION. AFTER THE HANDLE AND ADAPTER WERE SET, THE OPENING AND CLOSING CHECK WAS PERFORMED OUTSIDE THE BODY. AFTER THAT, THE DEVICE WAS INSERTED IN THE ABDOMINAL CAVITY, BUT THE JAWS WERE UNABLE TO BE OPENED. AFTER IT WAS REMOVED OUTSIDE BODY, IT WAS CALIBRATED BY REPEATEDLY REMOVING AND INSERTING THE BATTERY, AFTER THAT IT WAS CHECKED THAT THE JAWS WERE OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9922292 ↗
• MalfunctionMar 5, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A DISTAL GASTRECTOMY PROCEDURE, THE POWER HANDLE WAS ATTEMPTED TO BE FIRED, BUT IT DID NOT FIRE. ANOTHER POWER HANDLE TOGETHER WITH THE SAME RELOAD WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793494 ↗
• MalfunctionMar 5, 2020Misfire; Difficult or Delayed Activation; Misfire; Difficult or Delayed Activation

  ACCORDING TO THE REPORTER, DURING A PROXIMAL PANCREATICODUODENECTOMY, AT THE FIRST FIRING, THE CARTRIDGE STOPPED HALFWAY WHEN RESECTING THE STOMACH. AFTER THAT, WHEN TRYING TO REPLACE THE CARTRIDGE, THE RELEASE BUTTON OF THE ADAPTER DID NOT RETURN. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9792393 ↗
• MalfunctionMar 4, 2020Failure to Read Input Signal; Unintended Movement; Failure to Read Input Signal; Unintended Movement

  ACCORDING TO THE REPORTER, PRIOR TO LOW ANTERIOR RESECTION, DURING SET UP OF THE DEVICE, THERE WAS NO LIGHT WHEN LOADING THE RELOAD, AND THE SYSTEM WAS NOT REACTING WHEN PUSHING THE CLOSE BUTTON. ANOTHER RELOAD WAS USED FOR TESTING, AND THE SOUND DURING SET UP WAS STRANGE. WHEN THE LOADING UNIT WAS CONNECTED, IT STARTED TO MOVE AND ROTATE WITHOUT TOUCHING THE ROTATE BUTTON. SURGEON USED MANUAL STAPLER TO CONTINUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9785298 ↗
• MalfunctionMar 2, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING FIRST FIRING ON A LAPAROSCOPY-ASSISTED DISTAL GASTRECTOMY, WHEN THE RELOAD WAS ATTACHED INTO THE ADAPTER AND TRIED TO CHECK THE OPENING AND CLOSING, THE JAWS WERE UNABLE TO BE OPEN AND CLOSE. THE PRODUCT WAS NOT USED TO PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774965 ↗
• MalfunctionFeb 27, 2020Break; Component or Accessory Incompatibility; Break; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A PROBLEM LOADING THE ADAPTOR ONTO THE HANDLE, THE RING WHICH WAS LOCATED CONNECTING PART BETWEEN ADAPT AND HANDLE WAS BROKEN.

  Patient problems: No Information

  MAUDE report 9763580 ↗
• MalfunctionFeb 26, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RIGHT HEMICOLECTOMY, ON THE FIRST FIRING, THE OPENING AND CLOSING OF THE JAWS WERE ABLE TO BE PERFORMED, BUT THE RELOAD WAS UNABLE TO FIRE (THE ILLUMINATION AND FLASH OF THE GREEN BUTTON WERE NORMAL). THE RELOAD WAS REMOVED ONCE, AND IT WAS ABLE TO FIRE AFTER RELOADING. FOR THE SECOND FIRING, THE SAME EVENT OCCURRED, AND IT WAS RELOADED, BUT IT WAS UNABLE TO FIRE. FOR THE THIRD FIRING, IT WAS ABLE TO FIRE NORMALLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753410 ↗
• MalfunctionFeb 10, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD WAS ATTACHED TO HANDLE, AND THE OPENING AND CLOSING CHECK WAS PERFORMED WITHOUT ANY PROBLEM. AFTER THE TISSUE WAS CLAMPED, THE GREEN BUTTON WAS PRESSED BUT FIRING COULD NOT BE PERFORMED. ALTHOUGH A NEW RELOAD WAS USED, IT COULD NOT FIRE. THEN A NEW RELOAD WAS ATTACHED TO ANOTHER HANDLE AND ADAPTER, AND IT WAS ABLE TO BE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9686863 ↗
• MalfunctionJan 28, 2020Difficult to Open or Close; Positioning Problem; Difficult to Open or Close; Positioning Problem

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE REPORTED ADAPTER WITH PROCEDURES REMAINING LEFT WAS CONNECTED TO THE HANDLE, AND THE CARTRIDGE WAS ATTACHED, BUT THE JAWS OPEN/CLOSE AND ARTICULATION OF THE CARTRIDGE DID NOT RESPOND. THE ROTATION FUNCTIONED SUCCESSFULLY. THE GREEN LAMP FOR INDICATING THE CARTRIDGE STATUS ON THE LOWER SIDE OF THE HANDLE DID NOT ILLUMINATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637583 ↗
• MalfunctionJan 6, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO THE STOMACH DURING A ROBOTIC LAPAROSCOPIC GASTROPLASTY, THE STAPLER WAS ABLE TO FIRE BUT THERE WAS A STAPLE FORMATION ISSUE. IT WAS ALSO STATED THAT THE JAWS OF THE DEVICE LOCKED ON TISSUE. THE DOCTOR NEEDED TO FORCE THE DEVICE TO LOOSEN THE TISSUE. IT WAS CONFIRMED THAT TWO RELOADS HAD THE SAME MALFUNCTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9551151 ↗
• MalfunctionDec 23, 2019Device Remains Activated; Failure to Fire; Device Remains Activated; Failure to Fire

  ACCORDING TO THE REPORTER, AFTER CHANGING THE RELOAD TO PERFORM FIRING DURING A LAPAROSCOPIC COLECTOMY, THE BUTTON NO LONGER FUNCTIONED. WHEN THE DEVICES WERE COLLECTED, THE HANDLE DETECTED A RELOAD EVEN WHEN NO RELOAD WAS CONNECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9513003 ↗
• MalfunctionDec 20, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THORACOSCOPIC SURGERY RIGHT UPPER LOBECTOMY SURGERY, AFTER THE CALIBRATION WAS COMPLETED AND THE CARTRIDGE WAS ATTACHED, THE JAWS WHICH CLAMPED THE TISSUE WOULD OPEN AND CLOSED BUT DID NOT FIRE. A MANUAL STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Information

  MAUDE report 9506369 ↗
• MalfunctionDec 20, 2019Difficult to Open or Close; Human-Device Interface Problem; Difficult to Open or Close; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BARIATRIC SURGERY, WHEN THE RELOAD CLOSE BUTTON WAS PRESSED, THERE WAS NO RESPONSE - THE RELOAD WOULD NOT CLOSE TO CALIBRATE/RECOGNIZE IT AND THE ADAPTER UNLOCK BUTTON DID NOT WORK. THE ADAPTER WAS REPLACED AND THE STAPLING WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9503676 ↗
• MalfunctionDec 10, 2019Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPARO APPENDECTOMY, AT THE FIRST FIRING, AFTER SETTING UP THE HANDLE, IT WAS CHECKED THAT THE THREE GREEN LAMPS WERE ILLUMINATED WITHOUT ANY PROBLEMS, WHEN IT WAS ATTEMPTED TO FIRE THE RELOAD, THE PRODUCT WAS UNABLE TO FIRE. FURTHERMORE, THE STATUS LAMP ILLUMINATION ALSO HAD BEEN CHECKED BEFORE FIRING. THE HANDLE WAS ABLE TO FIRE AND NOTHING WAS NOT CLAMPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9442912 ↗
• MalfunctionNov 20, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, WHEN STAPLING THE STOMACH AND THEN SMALL INTESTINE ON A LAPAROSCOPIC GASTROPLASTY, THE STAPLER STOPPED AND DID NOT PROGRESS. A NEW RELOAD WAS USED BUT HAD THE SAME ISSUE. THE WHOLE DEVICE WAS CHANGED BUT SAME PROBLEM OCCURRED IT STOPPED MIDWAY. IT WAS REPORTED THAT THE STAPLE LINE WAS INCOMPLETE PROXIMALLY. A NEW MANUAL STAPLER AND RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9347872 ↗
• MalfunctionNov 20, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, WHEN STAPLING THE STOMACH AND THEN SMALL INTESTINE ON A LAPAROSCOPIC GASTROPLASTY, THE STAPLER STOPPED AND DID NOT PROGRESS. A NEW RELOAD WAS USED BUT HAD THE SAME ISSUE. THE WHOLE DEVICE WAS CHANGED BUT SAME PROBLEM OCCURRED IT STOPPED MIDWAY. IT WAS REPORTED THAT THE STAPLE LINE WAS INCOMPLETE PROXIMALLY. A NEW MANUAL STAPLER AND RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9347366 ↗