Endo GIA EGIA30CTAVRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10884521186101), received between Aug 29, 2017 and Apr 11, 2022 — classified as 5 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (16 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825); they may or may not involve this specific model.

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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING AN OPEN VIDEO-ASSISTED THORACOSCOPIC SURGERY LOBECTOMY, WHILE FIRING THE VESSEL, THE FIRST BATCH OF RELOAD WAS FIRED HALFWAY AND THEN STOP. UNABLE TO COMPLETE THE FIRING. THERE WAS A DIFFICULTY IN ATTACHING TO THE SIGNIA ADAPTOR IN THE SECOND BATCH OF RELOAD. A NEW STAPLER WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074363 ↗
• MalfunctionSep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, A SMALL BLEEDING OF THE VEIN WAS FOUND AFTER STAPLING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497737 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING USED FOR VESSEL MANIPULATION ON A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, BLEEDING FROM THE STAPLE LINE OCCURRED AFTER FIRING. HEMOSTASIS WAS DONE BY SUTURING WITH NEEDLE AND THREAD.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11047630 ↗
• MalfunctionDec 9, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN THE DEVICE WAS SET ON TISSUE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE TO FIRE. THE SURGEON REPLACED THE RELOAD TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10974923 ↗
• MalfunctionOct 7, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN STAPLING OVER A PULMONARY ARTERY BRANCH ON A LAPAROSCOPIC VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE HANDLE COULD NOT BE SQUEEZED. THE STAPLER WAS NOT ABLE TO FIRE. ANOTHER RELOAD WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10642393 ↗
• MalfunctionJul 17, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC RIGHT UPPER LOBECTOMY PROCEDURE, WHILE TRYING TO STAPLE THE RIGHT UPPER BRANCH OF THE RIGHT UPPER LOBE, THE DEVICE DID NOT FIRE. IT WAS ALSO REPORTED THAT PROPER LOAD-OPENING AND CLOSING OF THE JAWS WAS CHECKED PRIOR INSERTION, AND THE JAWS CLOSED FOR FIRING. THE GREEN BUTTON WAS PRESSED, AND THE HANDLE WAS RELEASED FOR FIRING, BUT THE HANDLE COULD NOT FIRE THE RELOAD AT ALL. THE RELOAD WAS TAKEN OUT AND WAS REPLACED WITH A NEW SECOND ONE, BUT THE SAME PROBLEM OCCURRED. THE RELOAD WAS REPLACED AND STILL USING THE SAME HANDLE, FIRED PROPERLY AND WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292389 ↗
• MalfunctionMar 11, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A LOBECTOMY, THE DEVICE WAS UNABLE TO FIRE WHEN APPROACHING BLOOD VESSEL. WHEN THE DISPLAY SCREEN WAS CHECKED, IT SHOWED THAT THE RELOAD WAS ALREADY USED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9818109 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING TRANSECTION OF PULMONARY VEINS ON A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, THE DEVICE FIRED AND, THERE WAS COMPLETE STAPLE LINE AND FORMATION, BUT THERE WAS BLEEDING FROM THE STAPLE LINE ON THREE SEPARATE VESSELS. CLIPS WERE USED TO ACHIEVE HEMOSTASIS.

  Patient problems: No Code Available

  MAUDE report 9504633 ↗
• MalfunctionDec 3, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A THORACO LOBECTOMY, AT THE SECOND FIRING, WHEN THE RELOAD WAS USED AT PULMONARY ARTERY TREATMENT, STAPLING AND RESECTION WERE FOUND TO BE IN THE CONDITION THAT ONLY PERFORMED TILL HALFWAY. THE BLOOD VESSEL WAS AT THE INNER SIDE OF THE CUT LINE, ANOTHER RELOAD WAS TAKEN OUT, BUT STAPLING AND RESECTION WERE ALSO STOPPED HALFWAY AS THE SAME, AND THE STAPLING OF PULMONARY ARTERY WAS COMPLETED WITH THE THIRD ONE. IT WAS IN THE CONDITION THAT ALL THREE CARTRIDGE¿S STAPLES HAD BEEN FIRED TO THE END. AFTER THAT, THE HANDLE WAS REPLACED, AND BRONCHUS WAS ABLE TO BE STAPLED NORMALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401828 ↗
• MalfunctionOct 11, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THORACO/LOBECTOMY, AT THE FIRST FIRING AFTER THE RELOAD WAS CONNECTED, ALTHOUGH THE GREEN BUTTON WAS PRESSED AND HANDLE COULD BE SQUEEZE TO PERFORM FIRING OPERATION, THE DEVICE COULD NOT BE FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9182180 ↗
• MalfunctionJul 8, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE FIRST FIRING IN A THORACO/LOBECTOMY PROCEDURE, THE HANDLE WAS CONNECTED WITH THE RELOAD AND WAS ATTEMPTED TO BE FIRED IN THE THORACIC CAVITY. HOWEVER, THE DEVICE WAS UNABLE TO BE FIRED. IT WAS NOTED THAT THE GREEN BUTTON WAS A BLE TO BE PRESSED BUT THE HANDLE WAS UNABLE TO BE SQUEEZED. THE HANDLE WAS REPLACED AND THAT SEVERAL UNITS OF CARTRIDGE WERE ABLE TO BE FIRED WITHOUT PROBLEMS, BUT AGAIN THE EVENT THAT THE DEVICE WAS UNABLE TO BE FIRED OCCURRED SIMILARLY. THE PROCEDURE WAS COMPLETED WITH REPLACING WITH A NEW DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8770087 ↗
• MalfunctionJun 26, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING DURING ESOPHAGECTOMY, THE SURGEON CLAMPED AZYGOS VEIN BUT COULD NOT FIRE THE DEVICE. THE DISPLAY SCREEN WAS CHECKED AND FOUND TO BE BLACKOUT. THE ADAPTER ERROR OCCURRED WHILE THE SETTING THE DEVICE AND STILL CONNECTED THE ADAPTER TO THE HANDLE TWICE. ALL DEVICES INCLUDED THE HANDLE WERE REPLACED, AND THE OPERATION COMPLETED WITHOUT PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8733246 ↗
• MalfunctionMay 15, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE FIRST FIRING FOR BLOOD VESSEL TREATMENT IN NEPHRECTOMY PROCEDURE, THE FIRING STOPPED IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8613068 ↗
• InjuryMar 28, 2019Failure 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 VIDEO ASSISTED THORACIC SURGERY, DURING TRANSECTION OF THE SUPERIOR PULMONARY VEIN, IT WAS REPORTED THAT THERE WAS AN INCOMPLETE STAPLE LINE AND IT BLED AFTER 2 FIRINGS. THEY NEEDED TO USE CLIPS TO CONTROL BLOOD LOSS.

  Patient problems: No Code Available

  MAUDE report 8461955 ↗
• MalfunctionMar 26, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC LOBECTOMY, AT THE FIRST FIRING, THE DEVICE WAS ABLE TO BE USED WITH NO PROBLEM WITH JAWS' OPENING AND CLOSING, APPROACHING TISSUE, AND UNTIL THE CLOSING OF THE JAWS, BUT AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED. A NEW CARTRIDGE WAS OPENED AND USED WITH THE SAME HANDLE, AND THEN THE DEVICE WAS ABLE TO BE USED WITH NO PROBLEM. 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 8451990 ↗
• MalfunctionJan 17, 2019Misfire; Misfire

  ACCORDING TO THE REPORTER, ON A LOBECTOMY, DURING THE TRANSECTION OF THE PULMONARY ARTERY, AT THE FIRST FIRING, THE KNIFE STOPPED ADVANCING. THE DOCTOR GOT THE ANVIL TO THE BACK SIDE AND CLOSED THE JAWS. THE DEVICE WAS FIRED AFTER CONFIRMING THAT THE GREEN BUTTON WAS FLASHING. AT THE BEGINNING OF THE FIRING, A TONE OF FIRING WAS HEARD, BUT THE KNIFE STOPPED ADVANCING IMMEDIATELY AND WOULD NOT MOVE EVEN THOUGH THE DOCTOR PRESSED THE FIRE BUTTON AGAIN. THE SURGICAL TIME WAS EXTENDED FOR NOT MORE THAN 30 MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8257044 ↗
• MalfunctionDec 21, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, WHEN ATTACHING THE CARTRIDGE TO THE DEVICE ON THE SECOND FIRING DURING A LOBECTOMY, THE FIRING STOPPED HALFWAY. THE SALES REPRESENTATIVE CONFIRMED THAT THE THREAD WENT FORWARD AND STAPLE PUSHER WAS PUSHED UP. IT WAS STATED THAT THERE WAS A HIGH POSSIBILITY THAT THE VENT OCCURRED BECAUSE OF THE ATTACHMENT OF THE CARTRIDGE AFTER THE FIRING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8191592 ↗
• MalfunctionDec 11, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LOBECTOMY, THE RELOAD WAS USED FOR TREATING THE VESSEL. AT THE FOURTH FIRING, AFTER CONFIRMING THAT THE RELOAD WAS CONNECTED, THE DOCTOR TRIED TO FIRE, BUT THE DEVICE COULD NOT FIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152878 ↗
• InjuryOct 9, 2018Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LUNG RESECTION, THE DOCTOR STARTED FIRING THE FIRST RELOAD AT THE TIME OF VEIN TREATMENT, WHEN AN ONOMATOPOEIC SOUND WAS HEARD AT THE TIP OF THE RELOAD, EVEN WHEN THE DOCTOR FIRED TO THE END AND RETURNED THE KNIFE, FROM NEAR THE TIP TO THE MIDDLE UNTIL THE KNIFE RETURNED, ONOMATOPOEIC SOUND WAS HEARD. AS A RESULT, THE TIP PART OF THE STAPLE LINE WAS NOT FORMED AND OOZING BLEEDING OCCURRED AS A RESULT OF THE ISSUE. A HEMOSTASIS TREATMENT WAS PERFORMED. A SIMILAR EVENT OCCURRED WHEN THE SECOND RELOAD WAS USED ON THE LUNG PULMONARY PARENCHYMA.

  Patient problems: No Code Available

  MAUDE report 7947106 ↗
• MalfunctionSep 11, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, FOR THE FIRST FIRING OF LOBECTOMY, THE SURGEON TRIED TO FIRE ULTRA HANDLE AND THE RELOAD; HOWEVER, THE HANDLE WAS STIFF AND THEY COULD NOT FIRE THE DEVICE. REPLACED BY A NEW CARTRIDGE, USING THE SAME HANDLE, AND THE FIRING WAS SUCCESSFUL AND THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THE STATUS OF THE PATIENT WAS REPORTED AS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7864405 ↗
• MalfunctionAug 31, 2018Failure 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 SEGMENTAL RESECTION OF LUNG AND THORACOSCOPY, ON THE FIRST FIRING, THEY CONNECTED THE DEVICE WITH NO PROBLEM. WHEN THE SURGEON STARTED TO FIRE THE DEVICE, THE JAWS DID NOT CLAMP A FOREIGN MATERIAL HOWEVER THE STAPLES WERE MALFORMED AND THE KNIFE DID NOT ADVANCE. OOZING NOTED AT THE DISTAL END OF THE RELOAD. AS VEIN WAS SHORT LENGTH, THE SURGEON FIRED NEW DEVICE TO THE ORIGINAL STAPLE LINE AND RESOLVED THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7836836 ↗
• MalfunctionJul 23, 2018Failure to Fire

  ACCORDING TO THE REPORTER: AT THE FIRST FIRING OF LOBECTOMY, THE SURGEON CONNECTED THE RELOAD TO A HANDLE AND CHECKED THE JAWS OPENING/CLOSING. THEN THE SURGEON TRIED TO FIRE THE DEVICE, HOWEVER COULD NOT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7710503 ↗
• MalfunctionJul 6, 2018Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING LOBECTOMY PROCEDURE, AT THE FOURTH FIRING, THE SURGEON CLAMPED THE VESSEL AND FIRED THE DEVICE AND THEY COULD STAPLE THE VESSEL, HOWEVER, THEY COULD NOT RESECT THE VESSEL. SURGEON CUT THE VESSEL BY SCISSORS AD ADDITIONALLY SUTURED IT BY TREAD. THE 5TH FIRING TO BRONCHUS BY THE SAME HANDLE WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7666562 ↗
• MalfunctionJul 6, 2018Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A THORASCOPIC LOBECTOMY, ON THE FIRST FIRING ON PULMONARY ARTERY RESECTION, THE SURGEON PUSHED THE CENTER CONTROL BUTTON DOWN AND STARTED FIRING THE DEVICE. HOWEVER, THE DEVICE SUDDENLY STOPPED AT THE FIRST FORCE MODE AND THE KNIFE DID NOT ADVANCE TO THE DISTAL END. THE SURGEON NOTED THAT THE VEIN WAS STAPLED PROPERLY AND THE TISSUE WAS NOT THICK. THEY USED ANOTHER DEVICE TO CONTINUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7666451 ↗
• MalfunctionJun 7, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A PULMONARY ARTERY RESECTION OF LOBECTOMY, THE SURGEON TRIED TO FIRE THE DEVICE, HOWEVER COULD NOT SQUEEZE THE HANDLE AT ALL. THE SURGEON DID NOT RE-CLAMPED THE TISSUE. THERE WAS LOW POTENTIAL OF PRE-FIRING. THE SALES REP NOTICED NO STAPLES EXPOSED FROM THE DISTAL END OF THE CARTRIDGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7578664 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825. One submission often covers many models, so check the product and lot details in each record.

• Z-0748-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection
• Z-0747-2021 · Nov 23, 2020 · Completed
  Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or tra
• Z-0002-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0004-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0005-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric
• Z-0007-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic
• Z-0003-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0008-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-0009-2021 · Aug 12, 2020 · Open, Classified
  Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading Units, Parent Codes 00Z2760 - Product Usage: The Endo GIA universal staplers have applicat
• Z-0001-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gyn
• Z-0006-2021 · Aug 12, 2020 · Open, Classified
  Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code 030455 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecolo
• Z-1264-2020 · Jan 17, 2020 · Terminated
  Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 58 more.