GIA GIA6038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 319 adverse event reports that list this exact device (DI 10884523007237), received between Sep 8, 2016 and Sep 21, 2026 — classified as 3 deaths, 62 injuries, 254 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (99 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825, K221013); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 319 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break; Detachment of Device or Device Component

  It was reported that during a bowel obstruction case of small bowel followed by anastomosis, two stapler jaws broke and the broken jaw part disengaged. No pieces fell into the patient cavity. The device was replaced with another reload to resolve the issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840489 ↗
• MalfunctionSep 21, 2026Break; Detachment of Device or Device Component

  It was reported that during a bowel obstruction case of small bowel followed by anastomosis, two stapler jaws broke and the broken jaw part disengaged. No pieces fell into the patient cavity. The device was replaced with another reload to resolve the issue. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840412 ↗
• MalfunctionSep 15, 2026Failure to Form Staple

  According to the reporter, during a procedure using a open stapler, the staple line was incomplete. The specific location of the incomplete staple line could not be identified; however, tissue closure was not performed smoothly. To resolve the issue, a new device of the same product type was opened and used.

  Patient problems: Tissue Breakdown

  MAUDE report 50766668 ↗
• MalfunctionJan 6, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE STAPLER DID NOT FIRE. ANOTHER STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23983891 ↗
• MalfunctionDec 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT COLON RESECTION, THE FIRING KNOB OF THE DEVICE BROKE OFF DURING TRANSECTION. THE BROKEN PART DISENGAGED BUT DID NOT FALL INTO THE PATIENT CAVITY. THE RESECTION WAS COMPLETED USING THE OTHER BLACK KNOB, AND A SECOND STAPLER WAS USED FOR THE SECOND FIRE. THE LAPAROSCOPIC PROCEDURE WAS CONVERTED TO OPEN, WHICH WAS NOT RELATED TO THE DEVICE PROBLEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882380 ↗
• MalfunctionSep 19, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN RIGHT COLECTOMY, THE OPEN STAPLER WAS USED FOR RESECTION OF A SEGMENT OF THE COLON OR POSSIBLY FOR MAKING THE ANASTOMOSIS. THE CASE WAS EXTENDED BY APPROXIMATELY HALF AN HOUR, THE STAPLES DID NOT DEPLOY AND THE KNIFE WAS DEPLOYED WITHOUT STAPLES DURING TISSUE RESECTION. IT REQUIRED SO MUCH MANIPULATION OF THE WHITE FLAG TO GET THE TWO SIDES TOGETHER AND THE SURGEON WOULD NOT HAVE BEEN ABLE TO DO THIS DURING THE CREATION OF THE ANASTOMOSIS. THE TISSUE WAS RESECTED AND RE-STAPLED DUE TO THE DEVICE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23092787 ↗
• MalfunctionSep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, AFTER FIRING THE RELOADABLE STAPLER, THE STAPLE LINE DID NOT HOLD AND SUBSEQUENTLY OPENED UP. THE DEVICE WAS REPLACED AND EXPLANTED.

  Patient problems: Tissue Breakdown

  MAUDE report 23022864 ↗
• MalfunctionAug 6, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE DID NOT FIRE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728804 ↗
• MalfunctionJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVELY OF SEGMENTAL SMALL BOWEL RESECTION, THERE WAS ANASTOMOTIC LEAK.

  Patient problems: Failure to Anastomose

  MAUDE report 22640549 ↗
• MalfunctionJul 25, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL COLON CANCER SURGERY, THE DEVICE PARTIALLY FIRED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608359 ↗
• MalfunctionJun 10, 2025Failure to Fire; Component or Accessory Incompatibility; Human-Device Interface Problem; Failure to Fire; Component or Accessory Incompatibility; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WAS DIFFICULT TO LOAD ON THE SECOND LOADING UNIT. WHEN IT WAS TIME TO STAPLE, THE DEVICE WAS UNABLE TO FIRE AND WAS DIFFICULT TO REMOVE THE RELOAD IN PLACE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175887 ↗
• MalfunctionApr 30, 2025Retraction Problem; Human-Device Interface Problem; Retraction Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING AN OPEN SIGMOID RESECTION, THERE WERE ISSUES WITH CHANGING THE RELOADS ON THREE STAPLERS, LEADING TO THE USE OF PRELOADED RELOADS. AFTER FIRING, THERE WERE DIFFICULTIES RETRACTING THE KNIFE BLADE. THE FIRST DEVICE WAS REPLACED BY TWO OTHER DEVICES, BUT ALL EXHIBITED THE SAME PROBLEM. THE DEVICES WERE REPLACED, AND IT WAS NOTED THAT THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937290 ↗
• MalfunctionApr 30, 2025Retraction Problem; Human-Device Interface Problem; Retraction Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING AN OPEN SIGMOID RESECTION, THERE WERE ISSUES WITH CHANGING THE RELOADS ON THREE STAPLERS, LEADING TO THE USE OF PRELOADED RELOADS. AFTER FIRING, THERE WERE DIFFICULTIES RETRACTING THE KNIFE BLADE. THE FIRST DEVICE WAS REPLACED BY TWO OTHER DEVICES, BUT ALL EXHIBITED THE SAME PROBLEM. THE DEVICES WERE REPLACED, AND IT WAS NOTED THAT THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937260 ↗
• MalfunctionApr 30, 2025Retraction Problem; Human-Device Interface Problem; Retraction Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING AN OPEN SIGMOID RESECTION, THERE WERE ISSUES WITH CHANGING THE RELOADS ON THREE STAPLERS, LEADING TO THE USE OF PRELOADED RELOADS. AFTER FIRING, THERE WERE DIFFICULTIES RETRACTING THE KNIFE BLADE. THE FIRST DEVICE WAS REPLACED BY TWO OTHER DEVICES, BUT ALL EXHIBITED THE SAME PROBLEM. THE DEVICES WERE REPLACED, AND IT WAS NOTED THAT THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21937058 ↗
• MalfunctionApr 18, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLE LINE WAS INCOMPLETE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 21866256 ↗
• MalfunctionMar 25, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLER INSTRUMENT DID NOT FIRE.

  Patient problems: Insufficient Information

  MAUDE report 21691816 ↗
• MalfunctionMar 10, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, THE FIRING KNOB COULD NOT BE PUSHED AND THE DEVICE COULD NOT BE FIRED. ANOTHER RELOAD WAS USED BUT DID NOT WORK EITHER. ANOTHER HANDLE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561441 ↗
• DeathFeb 20, 2025Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  THE PRODUCT WAS USED FOR A SMALL BOWEL RESECTION WITH ANASTOMOSIS. DURING SUBSEQUENT SURGERY IT WAS DISCOVERED THAT THE FREE END OF THE SMALL BOWEL STAPLE LINE HAD LEAKAGE ALONG THE STAPLE LINE INDICATIVE OF A FAILED STAPLE LINE AND THE ANASTOMOSIS DID NOT SEAL. IT WAS REPORTED THAT AFTER USE, THE PATIENT EXPERIENCED SURGICAL STAPLER FAILURE, FAILURE TO THE STAPLER DEVICE, BOWEL LEAKAGE, DEFECTIVE DEVICE, PAIN, SHOCK, MENTAL ANGUISH, UNABLE TO PERFORM NORMAL ACTIVITIES, LEUKOCYTOSIS, ASCITES, SEROSITIS, AND DEATH. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS, SMALL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS, DIVERTING LOOP ILEOSTOMY, & CT SCAN. INFORMATION RECEIVED INDICATES THE PATIENT IS DECEASED. NO INFORMATION WAS PROVIDED REGARDING THE CIRCUMSTANCES OF EXPIRATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ascites; Emotional Changes; Failure to Anastomose; Inflammation; Pain; Shock; Unspecified Tissue Injury

  MAUDE report 21425379 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY TO THE RIGHT HEMICOLECTOMY IT WAS FOUND THAT THERE WAS A STAPLE FORMATION ISSUE. THE SEGMENT THAT WAS REMOVED IN THE SECOND SURGERY WAS SENT TO PATHOLOGY AND THE OPENING OF THE STAPLE LINE WAS DETERMINED. A STAPLE LINE REINFORCEMENT WAS DONE TO RESOLVE THE ISSUE. IT WAS NOTED THAT THERE WAS AN EXTENDED HOSPITALIZATION OF TWO WEEKS AND THE PATIENT WAS SENT TO THE INTENSIVE CARE UNIT AS THE PATIENT WAS EXHIBITING SYMPTOMS OF ANASTOMOTIC LEAKAGE. THE PATIENT EXPERIENCED A LIFE THREATENING EVENT DUE TO SEPSIS IN THE ABDOMINAL CAVITY. AS A RESOLUTION ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED.

  Patient problems: Tissue Breakdown

  MAUDE report 21356219 ↗
• MalfunctionJan 29, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE GIA6038S STAPLER DEVICE, THE STAPLES DID NOT DEPLOY, RESULTING IN CUTTING WITHOUT STAPLING. THIS LED TO AN EXTENDED SURGICAL TIME BY 30 MINUTES. FECES WERE FOUND IN THE ABDOMEN, NECESSITATING AN INTERNAL WASH AND THE ADMINISTRATION OF EXTRA ANTIBIOTICS. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE AND RESECTING AND RE-STAPLING THE AFFECTED AREA.

  Patient problems: Tissue Breakdown

  MAUDE report 21263286 ↗
• MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A RADICAL RESECTION OF COLON CANCER IN THE OPERATING ROOM, THE HEPATOBILIARY AND PANCREATIC LAPAROSCOPIC SURGERY DEPARTMENT PLANNED TO ANASTOMOSE THE COLON STUMPS. THE MIDDLE BUCKLE OF THE STAPLER POPPED UP BY ITSELF AND COULD NOT BE CLOSED NORMALLY, SO THE STAPLER HAD TO BE REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21170518 ↗
• MalfunctionDec 13, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A WHIPPLE'S PROCEDURE ON THE THIRD FIRING THE BLACK KNOB WOULD NOT ADVANCE AND THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924867 ↗
• MalfunctionNov 28, 2024Mechanics Altered; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS ABLE TO BE FIRE HOWEVER THE STAPLES DID NOT DEPLOY AND THE DEVICE WAS ABLE TO CUT THE TISSUE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20806032 ↗
• MalfunctionNov 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE STAPLER DID NOT FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759816 ↗
• MalfunctionNov 12, 2024Retraction Problem; Component or Accessory Incompatibility; Retraction Problem; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING AN OPEN WHIPPLE, DURING RESECTING THE BOWEL, AFTER FIRING THE SECOND TIME, THE KNIFE BLADE DID NOT GO DOWN. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20670192 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825, K221013. 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 tr
• 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-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-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-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-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-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-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-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-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-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-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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

…and 58 more.