Endo GIA 030453Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884523002843), received between Oct 2, 2017 and Apr 3, 2023 — classified as 1 death, 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LUNG RESECTION PROCEDURE, WHEN THE FIRST RELOAD WAS FIRED AT THE TIME OF LUNG RESECTION, THE STAPLE LINE WAS CENTRALLY INCOMPLETE AND THE DISTAL AND PROXIMAL STAPLES HAD POOR FORMATION. A SECOND RELOAD WAS USED, BUT THE SAME ISSUES OCCURRED. A THIRD RELOAD WAS USED, BUT THE STAPLE LINE WAS ALSO INCOMPLETE AND THE FORMATION OF THE FIRED STAPLES WERE POOR. THE SURGEON SUTURED THE STAPLE LINE AND USED A NEW DEVICE TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16666108 ↗
• MalfunctionOct 6, 2021Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, WHEN CHECKING THE OPENING AND CLOSING, THE DEVICE BECAME UNABLE TO OPEN. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12587077 ↗
• DeathSep 16, 2021Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING AN OPEN ABDOMINAL SURGERY (LAPAROTOMY, HEPATIC LEFT LOBE RESECTION), IT WAS CONFIRMED THAT THE ANVIL OF THE RELOAD CURVED TOWARDS THE TIP. A FEW SECONDS AFTER THE FIRING WAS PERFORMED AND RELEASED, THERE WAS BLEEDING FROM THE CENTRAL SIDE, AND THE STAPLE FORMATION STATUS OF THE STAPLE LINE COULD NOT BE CHECKED. ON LEFT HEPATIC LOBECTOMY, LYMPH NODE RESECTION WAS PERFORMED AND THE LEFT HEPATIC VEIN WAS RESECTED AT THE ROOT, AND THE ANVIL OF THE RELOAD WAS APPROACHED TO THE BLOOD VESSEL PERPENDICULARLY WITH THE DORSAL SIDE, SO IT WAS APPROACHED BY ARTICULATING ABOUT 2 ARTICULATIONS TO THE RIGHT SO THAT THE BLOOD VESSEL WAS INSIDE OF THE CARTRIDGE CUTLINE, AND FIRING WAS PERFORMED. IT WAS SAID THAT THE FIRING RESISTANCE WAS THE SAME AS USUAL. ALSO, THE THICKNESS OF THE BLOOD VESSEL AND TISSUE FRAGILITY WERE NOT PARTICULARLY THICK OR FRAGILE. CARDIAC ARREST OCCURRED DURING THE OPERATION. TO RESOLVE THE ISSUE, THE CARDIOVASCULAR SURGERY PHYSICIAN ALSO ADDED A MEDIAN STERNOTOMY TO BLOCK THE IVC FROM THE INTRATHORACIC CAVITY AND RECONSTRUCT THE IVC. THE DAMAGED LEFT HEPATIC VEIN WAS SUTURED AFTERWARDS. AFTER SUTURING THE LEFT HEPATIC VEIN, THE WOUND WAS CL

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12482800 ↗
• MalfunctionOct 23, 2020Component or Accessory Incompatibility; Difficult to Open or Close; Component or Accessory Incompatibility; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC NEPHRECTOMY, THE JAWS WOULD NOT OPEN AND CLOSE; HENCE, THE NURSE COULD NOT CHECK THE OPENING AND CLOSING DURING THE SET-UP. IN ADDITION, THERE WAS DIFFICULTY LOADING THE RELOAD ONTO THE HANDLE. THE PRODUCT WAS NOT USED TO THE PATIENT. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10730549 ↗
• MalfunctionApr 1, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE INFERIOR MESENTERIC ARTERIAL TRANSECTION ON A LAPAROSCOPIC SIGMOIDECTOMY, THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911540 ↗
• InjuryMar 4, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOBECTOMY PROCEDURE, THE DEVICE HAD INCOMPLETE STAPLE LINE DISTALLY. TO RESOLVE THE ISSUE THE SURGEON THEN HAD TO MANUALLY SUTURED THE TISSUE, AND USED ANOTHER DEVICE IN ORDER TO COMPLETE THE CASE.

  Patient problems: No Code Available

  MAUDE report 9786057 ↗
• MalfunctionMay 10, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LOBECTOMY, AT THE THIRD FIRING, IN ORDER TO RESECT BLOOD VESSEL, AFTER CLAMPED, THE GREEN BUTTON WAS PRESSED BUT FIRING WAS UNABLE TO BE PERFORMED. THE HANDLE CANNOT BE SQUEEZED AS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 8601896 ↗
• MalfunctionJan 16, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING GASTRECTOMY AND WHILE STAPLING THE VESSEL, THE STAPLER DID NOT FIRE. THE DOCTOR REMOVED THE BROKEN ONE AND REPLACED BY A NEW STAPLER AND RELOAD TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8254221 ↗
• MalfunctionAug 9, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, WHILE CUTTING THE PULMONARY VESSEL IN A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, THE SURGEON FOUND THAT THE HANDLE COULD NOT BE SQUEEZED AND IT COULD NOT FIRE THE RELOAD. THE GREEN BUTTON WAS PRESSED. THEY USED ANOTHER DEVICE TO CONTINUE WITH THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7768932 ↗
• MalfunctionJul 30, 2018Failure to Fire; Firing Problem; Failure to Fire

  ACCORDING TO THE REPORTER, WHEN LIGATING THE VESSEL DURING A LAPAROSCOPIC PULMONARY WEDGE RESECTION, THE SURGEON WAS ABLE TO PRESS T HE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE AND THE STAPLER WAS NOT ABLE TO FIRE. THEY REPLACED THE ORIGINAL RELOAD WITH A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7732779 ↗
• MalfunctionJul 9, 2018Failure to Fire; Firing Problem; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, AFTER THE DEVICE WAS ASSEMBLED, THE SURGEON COULD NOT SQUEEZE THE HANDLE AND COULD NOT FIRE THE DEVICE. THEY THEN USED ANTHER DEVICE TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7671527 ↗
• MalfunctionJun 21, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LOW ANTERIOR RESECTION SURGERY, WHILE GRASPING RECTUM, THE GREEN BUTTON WAS PUSHED AND ENTER IN FIRING MODE HOWEVER THE HANDLE DID NOT FIRE ALTHOUGH THE CENTER CONTROL DOWN WAS PUSHED MULTIPLE TIMES. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THEY OPENED NEW HANDLE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625131 ↗
• MalfunctionMay 8, 2018Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS BEING APPLIED TO MESOAPPENDIX ON A LAPAROSCOPIC APPENDECTOMY, THE STAPLE LOAD WOULD NOT COMPLETELY CLOSE ON THE TISSUE. THEY USED A NEW STAPLE CARTRIDGE AND IT WORKED FINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7494543 ↗
• MalfunctionApr 17, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, WHEN ON LOBECTOMY ON THE LUNG TUMOR, THE STAPLER AND LOAD DID NOT FIRE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND THE HANDLE DID NOT SQUEEZE. AS STATED, THEY REPLACED A NEW STAPLER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7436789 ↗
• MalfunctionMar 22, 2018Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING TO THE ROOT OF INFERIOR MESENTERIC ARTERY DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE STAPLER DID NOT FIRE. THE DISPLAY SCREEN SHOWED THE INDICATOR OF THE CARTRIDGE WAS READY FOR USE. THE SURGEON RE-CLAMPED THE TISSUE AND PUSHED THE GREEN BUTTON THEN TRIED TO FIRE THE DEVICE, HOWEVER HE COULD NOT. THEY REPLACED THE STAPLER WITH A NEW CARTRIDGE ,AND THE FIRING WAS COMPLETED WITH NO PROBLEM. THE SALES REP NOTED THAT THE STAPLES DID NOT APPEAR FROM THE STAPLE POCKETS OF THE PROXIMAL END. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7362797 ↗
• MalfunctionFeb 7, 2018Failure to Fire; Mechanical Jam; Failure to Fire; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SECOND LOAD WAS NOT WORKING PROPERLY. AFTER THE STAPLER CLAMPED DOWN ON THE TISSUE, THE GREEN FIRE BUTTON WAS PRESSED BUT THE HANDLE JAMMED AND WAS UNABLE TO FIRE. THEY WERE ABLE TO OPEN THE HANDLE AND REMOVE THE DEVICE FROM THE PATIENT, THE SURGEON WAS ALSO UNABLE TO SQUEEZE THE HANDLE. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7247716 ↗
• MalfunctionJan 7, 2018Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY PROCEDURE THE DEVICE PARTIALLY FIRED, THERE WAS POOR STAPLE FORMATION AND THE STAPLE LINE WAS INCOMPLETE AT THE DISTAL END. TO COMPLETE THE PROCEDURE, A NEW DEVICE WAS USED. THERE WAS NO HARM CAUSED TO THE PATIENT. CURRENT PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7170900 ↗
• MalfunctionOct 2, 2017Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER: OCCURRED DURING A LOBECTOMY PROCEDURE. USED THE MANUAL STAPLING HANDLE WITH A RELOAD. THE SURGEON TRIED TO FIRE THE DEVICE, HOWEVER, COULD NOT. REPLACED BY A NEW HANDLE AND A NEW RELOAD AND THE FIRING WAS COMPLETED WITH NO PROBLEM. THERE WAS NO PATIENT HARM. THE STATUS OF THE PATIENT IS NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6908539 ↗

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-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-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-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-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-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-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-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-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-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-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-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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

…and 58 more.