GIA GIA8038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,237 adverse event reports that list this exact device (DI 10884523007268), received between Jul 19, 2016 and Sep 16, 2026 — classified as 12 deaths, 259 injuries, 966 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (384 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,237 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break; Human-Device Interface Problem

  It was reported that during a laparoscopic radical colon cancer resection, the reload could not be removed for replacement while tra nsecting colon tissue extracorporeally. It was also reported that the device broke. The stapler was replaced with another manufacturer's product and the procedure was completed. No device components fell into the patient cavity and no patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785440 ↗
• MalfunctionSep 15, 2026Failure to Form Staple

  According to the reporter, during a procedure, the open stapler did not complete sealing the area. There was gap of unstapled areas in the colon. A back-up stapler was used to resolve the issue.

  Patient problems: Tissue Breakdown

  MAUDE report 50766520 ↗
• MalfunctionAug 27, 2026Failure to Form Staple

  It was reported that during an open bowel resection surgery for intestinal obstruction, on cutting and anastomosis, an incomplete staple line occurred. The issue was repaired by oversewing with suture reinforcement.

  Patient problems: Tissue Breakdown

  MAUDE report 50479031 ↗
• MalfunctionAug 14, 2026Retraction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50263363 ↗
• MalfunctionJul 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PREOPERATIVELY, DURING SET-UP, A PLASTIC FELL OFF ONE LEG OF THE STAPLER AS THE DEVICE WAS REMOVED FROM THE PACKAGE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25679198 ↗
• MalfunctionMay 29, 2026Detachment of Device or Device Component; Firing Problem

  ACCORDING TO THE REPORTER, THE WHITE HANDLE ON THE NON-CUTTING SIDE OF THE STAPLER FELL OFF WHEN BEING HANDLED AND MADE THE STAPLER DIFFICULT TO HANDLE AND FIRE. IT OFTEN DOES NOT GO BACK ON CORRECTLY, MAKING THE SURGEON USE THE STAPLER WITHOUT THE WHITE HANDLE PIECE.

  Patient problems: Insufficient Information

  MAUDE report 25337375 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  AACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE JAWS OF THE STAPLER BROKE AND THE PARTS DISENGAGED. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175250 ↗
• MalfunctionApr 30, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN BOWEL RESECTION, THE STAPLES DID NOT DEPLOY, RESULTING IN CUTTING WITHOUT STAPLING. THE DEVICE WAS REPLACED BY OPENING ANOTHER STAPLER AND LOADING UNIT.

  Patient problems: Tissue Breakdown

  MAUDE report 25050219 ↗
• MalfunctionApr 24, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN SMALL BOWEL RESECTION, THE DEVICE WOULD NOT ADVANCE OR ¿SLIDE¿ TO FIRE. THE DEVICE WAS REPLACED 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 24977792 ↗
• MalfunctionApr 22, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE FIRING KNOB FELL OFF. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958136 ↗
• MalfunctionApr 20, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MESH REPAIR, SMALL RESECTION, COLON RESECTION, ABDOMINAL WALL RECONSTRUCTION PROCEDURE, THE TWO DEVICES FAILED TO DEPLOY THE STAPLES AND NO TISSUE WAS CUT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 24926304 ↗
• MalfunctionApr 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE FELL APART. THE ISSUE WAS ADDRESSED BY REPLACING THE DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24921443 ↗
• MalfunctionApr 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A MESH REPAIR, SMALL RESECTION, COLON RESECTION, ABDOMINAL WALL RECONSTRUCTION PROCEDURE, THE TWO DEVICES FAILED TO DEPLOY THE STAPLES AND NO TISSUE WAS CUT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED.

  Patient problems: Insufficient Information

  MAUDE report 24921360 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAST FIRING IN AN OPEN ILEOCECAL COLON RESECTION, THE GRIP OF THE STAPLER BROKE. THE WHITE HANDLE SEPARATED FROM THE METAL FRAME ON THE CARTRIDGE/FIRING PORTION OF STAPLER. NO DEVICE COMPONENT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744146 ↗
• MalfunctionMar 10, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN COLON CANCER SURGERY, DURING INTESTINAL SIDE-TO-SIDE ANASTOMOSIS, DURING FIRING WITH THE RELOADABLE LINEAR STAPLER, THE BLACK PUSH ROD TOOK A LOT OF FORCE TO PUSH IT EVEN A LITTLE BIT. AFTER THAT, A NEW RELOAD WAS LOADED INSTEAD, BUT THE BLACK PUSH ROD WAS VERY DIFFICULT TO PUSH. ANOTHER DEVICE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560697 ↗
• MalfunctionMar 2, 2026Break

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE INSTRUMENT BROKE. THE DEVICE WAS REPLACED 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 24478220 ↗
• MalfunctionFeb 18, 2026Failure to Align

  IT WAS REPORTED THAT DURING A BOWEL RESECTION, PRIOR TO USE THE DEVICE WAS NOT PROPERLY HINGED TOGETHER WHEN GIVEN TO THE SURGEON AND WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378699 ↗
• MalfunctionFeb 17, 2026Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A RIGHT HEMICOLECTOMY, AFTER THE FIRST RELOAD WAS INSTALLED, THE RELOAD COULD NOT BE FIRED. EVEN AFTER REMOVING THE STAPLE AND REINSTALLING, IT STILL COULD NOT BE FIRED. IT WAS THEN REPLACED WITH A 45 PURPLE STAPLE, WHICH FIRED SUCCESSFULLY. AS FOR THE OPEN STAPLER, AFTER OPENING THE PACKAGE, THE CIRCULATING NURSE FOUND THAT SOME STAPLES WERE MISSING FROM THE STAPLE LINE, SO IT WAS REPLACED DIRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24362029 ↗
• MalfunctionFeb 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. THE WHITE FLAG INTERLOCK/KNIFE BLADE COVER WAS NOT ENGAGED, AND THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24355136 ↗
• MalfunctionFeb 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED AT ALL. THE INSTRUMENT DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER STAPLER OF THE SAME TYPE.

  Patient problems: Insufficient Information

  MAUDE report 24350999 ↗
• MalfunctionFeb 9, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY, THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED, AND THE DEVICE DID NOT FIRE. THE ISSUE WAS RESOLVED BY REPLACING THE HANDLE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24300949 ↗
• MalfunctionFeb 3, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING AN OPEN BOWEL RESECTION, THE STAPLER WAS FIRED TO CREATE THE ANASTOMOSIS, AND WHILE THE DEVICE CUT THE TISSUE, NO STAPLES WERE DEPLOYED. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 24246687 ↗
• MalfunctionJan 2, 2026Misfire

  IT WAS REPORTED THAT DURING AN OPEN PARTIAL HEPATECTOMY, THE HANDLE AND RELOAD PARTIALLY FIRED AND COULD NOT CONTINUE OPERATION AFTER THE BLACK HANDLE WAS PUSHED HALFWAY. THE SURGEON ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE DEVICE WITH A NEW RELOAD, BUT THE DEVICE STILL COULD NOT CONTINUE. THE SURGEON THEN REPLACED IT WITH A NEW HANDLE AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23952497 ↗
• MalfunctionDec 24, 2025Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE BOWEL RESECTION, THE HANDLE BROKE. THE STAPLER WOULD JUST NOT ENGAGE OR FIRE. THE SURGEON WAS UNABLE TO PROPERLY REATTACH THE HANDLE PIECE, SO ANOTHER STAPLER FROM A DIFFERENT LOT NUMBER WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23891372 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY OF A LAPAROSCOPY DIAGNOSTIC CONVERTED TO OPEN LAPAROTOMY FOR RELEASE OF SMALL BOWEL OBSTRUCTION ON (B)(6) 2025, AFTER INFORMED CONSENT WAS OBTAINED, THE PATIENT WAS GIVEN PREOPERATIVE INTRAVENOUS (IV) FLUIDS AND IV ANTIBIOTICS. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM TABLE AND PLACED IN SUPINE POSITION. A TIME OUT WAS COMPLETED. THE ABDOMEN WAS PREPPED AND DRAPED IN THE USUAL STERILE FASHION. THE SURGEON REOPENED THE LEFT MID QUADRANT 5 MM INCISION AND INSERTED A 5 MM CAMERA COMPLEX UNDER DIRECT VISION TO THE ABDOMEN, NO TROCAR INJURY APPRECIATED. THE DOCTOR THEN PLACED A RIGHT LOWER RIGHT UPPER QUADRANT SECONDARY 5 MM TROCAR; NO TROCAR INJURY WAS APPRECIATED. UPON ENTERING THE ABDOMEN THERE WAS NO PURULENT OR FECULENT CONTAMINATION THERE WAS NO FLUID IN THE ABDOMEN THERE WAS DILATED PROXIMAL SMALL BOWEL AND DISTAL DECOMPRESSED SMALL BOWEL WAS ABLE TO LOCATE THE TERMINAL ILEUM AND FOLLOW THE DECOMPRESSED BOWEL BACK TO THE ROOT OF THE SMALL BOWEL MESENTERY HOWEVER THE SURGEON WAS UNABLE TO KEEP THE DILATED SMALL BOWEL OUT OF THE WAY THEREFORE OPENED THE PREVIOUS MIDLINE LAPAROTOMY INCISION THE DOCTOR WAS ABLE TO FOLLOW THE DECOMPRESS

  Patient problems: Obstruction/Occlusion

  MAUDE report 23890737 ↗

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-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 tr
• 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-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-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-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-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-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-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

…and 58 more.