Endo GIA EGIATRS45AXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 10884521190993), received between Aug 10, 2017 and Jun 3, 2022 — classified as 2 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (42 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.

• MalfunctionJun 3, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14598132 ↗
• MalfunctionApr 27, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN LUNG TRANSPLANT, THE GREEN COULD BE PRESS AND COULD SQUEEZE THE HANDLE, BUT THE STAPLER WOULD NOT FIRE. A NEW HANDLE WAS USED, BUT THE SAME BLACK RELOAD STILL COULD NOT FIRE. HENCE, A NEW BLACK RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732200 ↗
• MalfunctionSep 9, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN THE DEVICE APPROACHED THE LUNG PARENCHYMA AND ATTEMPTED TO PERFORM FIRING DURING A WEDGE RESECTION, THE FIRING FAILED. ANOTHER RELOAD WAS USED AND THE FIRING WAS PERFORMED. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507476 ↗
• MalfunctionSep 4, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING DURING A WEDGE/ SEGMENTAL RESECTION, THE RELOAD WAS CONNECTED TO THE HANDLE AND THE DEVICE WAS TRIED TO BE FIRED, BUT THE HANDLE WAS UNABLE TO BE SQUEEZED AND THE FIRING WAS UNABLE TO BE PERFORMED AT ALL. A NEW RELOAD WAS USED WITH THE ORIGINAL HANDLE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10493049 ↗
• MalfunctionSep 2, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A THORACIC WEDGE SEGMENTAL RESECTION, THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10482152 ↗
• MalfunctionFeb 12, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING STOMACH INTESTINAL PYLORUS SPARING (SIPS) BARIATRIC PROCEDURE, UPON FIRING ACROSS STOMACH TISSUE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WOULD NOT SQUEEZE THE HANDLE AND THE DEVICE DID NOT FIRE. A NEW HANDLE AND RELOAD WERE OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700708 ↗
• MalfunctionOct 21, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A THORACO LOBECTOMY PROCEDURE, WHEN THE THIRD RELOAD WAS USED FOR FIRING, THE JAWS WILL NOT OPEN AND CLOSE SMOOTHLY. BOTH THE HANDLE AND THE RELOAD WERE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216624 ↗
• MalfunctionOct 11, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACO/PNEUMOTHORAX PROCEDURE, WHEN THE DEVICE WAS ATTEMPTED TO BE USED, THE DEVICE DID NOT FIRE. A NEW RELOAD WITH THE SAME HANDLE WAS USED TO COMPLETE THE PROCEDURE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE DEVICE WAS NOT USED ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182299 ↗
• MalfunctionJul 29, 2019Break; Component or Accessory Incompatibility; Detachment of Device or Device Component; Break; Component or Accessory Incompatibility; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE RELOAD WAS UNABLE TO BE ATTACHED TO HANDLE. THE HANDLE HAS BEEN USED THREE TIMES PRIOR. ASSISTANCE WAS GIVEN TO THE SCRUB NURSE TO TRY AND ATTACH THE RELOAD, BUT AFTER SEVERAL TRIES, A NEW RELOAD WAS OPENED AND USED WITHOUT ISSUE. A PIECE OF BLACK PLASTIC WAS LATER FOUND DISLODGED FROM THE CONNECTION END OF THE RELOAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8839753 ↗
• MalfunctionJul 25, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING GASTRIC SLEEVE PROCEDURE, WHEN TRYING TO STAPLE THE STOMACH, THE STAPLER DID NOT FIRE. THE RELOAD WAS DISCARDED AND A NEW ONE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829314 ↗
• MalfunctionJul 23, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING OPEN DISTAL PANCREATECTOMY, THE STAPLER DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT HANDLE COULD NOT BE SQUEEZED. THE SURGEON DID NOT USE STAPLER IN THE END, USED DISSECTOR AND SEWN THE PANCREAS BY HAND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817776 ↗
• MalfunctionJul 1, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTROPLASTY PROCEDURE, THE 3 RELOADS WERE STUCK. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, THE STAPLING COULD NOT BE PERFORMED. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES AS IT TOOK TIME TO GET ANOTHER LOAD TO CHANGE. NEW LOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751051 ↗
• MalfunctionApr 15, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING WEDGE/SEGMENTAL RESECTION, AFTER CONNECTING THE CARTRIDGE TO THE HANDLE, THE OPENING AND CLOSING OF THE JAWS WAS CHECKED FOR US. AT THE SECOND FIRING, WHEN THE DOCTOR TRIED TO PERFORM FIRING, THE DEVICE COULD NOT FIRE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514167 ↗
• MalfunctionApr 11, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING COIL VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WEDGE RESECTION WITH BRONCHOSCOPY, THERE WERE TWO(2) STAPLERS AND FOUR(4) RELOADS THAT DID NOT FIRE CORRECTLY OR CUT THROUGH TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8504665 ↗
• MalfunctionMar 18, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC VIDEO-ASSISTED THORACIC SURGERY (VATS) LOBECTOMY, WHILE TRYING TO STAPLE ON A BLOOD VESSEL, AFTER CLOSING ON THE TISSUE, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER HANDLE AND RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430036 ↗
• MalfunctionFeb 6, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN ATTEMPTING TO APPROACH THE TISSUE AND FIRE THE DEVICE DURING A LUNG RESECTION, THEY WERE ABLE TO PRESS THE GREEN BUTTON BUT WERE NOT ABLE TO SQUEEZE THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8310825 ↗
• MalfunctionDec 18, 2018Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS USED FOR BULLAE RESECTION OF THE LUNG EMPHYSEMA'S APICAL PART IN THORACO/PNEUMOTHORAX PROCEDURE, THE EVENT OCCURRED AT THE THIRD FIRING. THE SURGEON FELT THAT THE TISSUE WERE THICK AND THE FIRING WAS STIFF. THE THIRD FIRING APPROACHED AT AN ANGLE ORTHOGONAL TO THE SECOND FIRING'S STAPLE LINE WITHOUT ARTICULATING. THE JAWS OPENED AND THE SURGEON WAS UNABLE TO CLOSE IT, SO SURGEON PRESSED THE FIRE BUTTON WHILE SQUEEZING THE HANDLE. SURGEON ATTEMPTED TO FIRE BUT THE STAPLES DID NOT ADVANCE SO A RELOAD WAS REPLACED. WHEN THE SURGEON ATTEMPTED TO FIRE, AN ABNORMAL SOUND WAS HEARD. THE HANDLE COULD NOT BE RETURNED FROM THE SQUEEZING POSITION, SO SURGEON RELEASED IT AND REPLACED THE HANDLE. THE LEAK TEST WAS ALSO FINISHED WITHOUT ABNORMALITY AND THE OPERATION WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8175945 ↗
• 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 8037543 ↗
• MalfunctionNov 5, 2018Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN THEY INSERTED THE RELOAD DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE ARROWS WOULD NOT ALIGN, AND A PIECE AT THE BASE OF THE RELOAD WAS LOOSE AND THEN DISLODGED, AND IT BROKE OFF. THEY USED ANOTHER RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8037217 ↗
• MalfunctionSep 20, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MINI GASTRIC BYPASS, ON STOMACH TRANSECTION, THE HANDLE WAS ABLE TO FIRE A LOAD INITIALLY WITHOUT INCIDENT. WHILE TRYING TO PERFORM THE SECOND FIRING, THE KNIFE BLADE AND STAPLES DID NOT ADVANCE. THE GREEN BUTTON WAS ACTIVATED, THE RING HANDLE KICKED OUT, BUT THEN UPON PULLING THE RING HANDLE IT WOULD SQUEEZE AS PER USUAL, BUT THERE WAS NO ACTIVITY WITHIN THE STAPLE LOAD. THE TEETH DID NOT ENGAGE THE PUSHING MECHANISM. THIS WAS EVIDENT AGAIN UPON TESTING POST-OPERATIVELY. NO MALFUNCTION WAS APPARENT DURING THE FIRST SUCCESSFUL FIRING OF THE STAPLER. A NEW PRODUCT WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7894748 ↗
• MalfunctionSep 18, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, ON STAPLING THE STOMACH, THE STAPLER WAS NOT ABLE TO FIRE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND THE HANDLE DID NOT SQUEEZE. THE STAPLER MADE A SNAPPING SOUND AND THE RELOAD KEPT JAMMING. NO CUTTING WAS PERFORMED. ANOTHER HANDLE AND RELOADS WERE USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7886011 ↗
• MalfunctionSep 18, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHILE PERFORMING INITIAL FIRING OF SLEEVE, THE SURGEON CLAMPED ON STOMACH TISSUE, PRESSED GREEN BUTTON AND TRIED TO FIRE THE DEVICE. THEY SQUEEZED HARDER THE HANDLE AND HEARD A CRACK ON IT BUT THE DEVICE DID NOT FIRE. A NEW HANDLE AND RELOAD WERE OBTAINED AND PROCEDURE WENT FORWARD AS USUAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7885506 ↗
• MalfunctionAug 30, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, THE STAPLER WAS NOT ABLE TO FIRE. ONCE CLOSED AND THE GREEN BUTTON ACTIVATED TO LOCK ON THE TISSUE, THE RELOAD RELEASED WIDE OPEN. THE CORRECT PROCESS WAS TRIED SEVERAL TIMES TO SEE IF THE PRODUCT WOULD CORRECT ITSELF. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7833937 ↗
• MalfunctionAug 30, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, ON INITIAL FIRING, THE SURGEON WAS NOT ABLE TO SQUEEZE THE HANDLE AND THE DEVICE DID NOT FIRE. THE RELOAD WOULD NOT FIRE, ANOTHER RELOAD WAS USED, WHICH DID FIRE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7833041 ↗
• MalfunctionJul 5, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING OF LOBECTOMY, THE SURGEON TRIED TO FIRE A MANUAL SHORT HANDLE, HOWEVER COULD NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7663504 ↗