GIA GIA10038LRecalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 10884521031661), received between Mar 17, 2017 and Sep 29, 2026 — classified as 1 death, 47 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (84 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Form Staple

  According to the reporter, during an open radical gastrectomy, when dividing the distal stomach, two staples consecutively burst out during use of the loading units. The staples did not form a proper B shape. Additionally, after the divided remnant stomach was removed, part of the middle section of the staple line had no staples. Finally, the procedure was completed by hand suturing.

  Patient problems: Tissue Breakdown

  MAUDE report 50935121 ↗
• MalfunctionSep 29, 2026Failure to Form Staple

  According to the reporter, during an open radical gastrectomy, when dividing the distal stomach, two staples consecutively burst out during use of the loading units. The staples did not form a proper B shape. Additionally, after the divided remnant stomach was removed, part of the middle section of the staple line had no staples. Finally, the procedure was completed by hand suturing.

  Patient problems: Tissue Breakdown

  MAUDE report 50935079 ↗
• MalfunctionSep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50778895 ↗
• MalfunctionFeb 26, 2026Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE HAD UNSPECIFIED FIRING ISSUES. ANOTHER LOADING UNIT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452442 ↗
• MalfunctionJan 29, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN GASTRECTOMY PROCEDURE, THE INSTRUMENT DID NOT FIRE WHILE BEING APPLIED TO CLAMP THE STOMACH. THE DEVICE WAS REPLACED WITH ANOTHER RELOAD TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208026 ↗
• MalfunctionNov 20, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE OPEN STAPLER DID NOT FIRE PRIOR TO USE. THE DEVICE WAS REPLACED WITH A NEW PRODUCT. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605043 ↗
• MalfunctionNov 3, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT FIRE. THE DEVICE WAS REPLACED WITH A NEW LOADING UNIT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459042 ↗
• MalfunctionOct 16, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN TOTAL GASTRECTOMY, ON THE FIRST FIRING, THE BLACK FIRING KNOB DID NOT ADVANCE AT ALL. A NEW LOADING UNIT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310008 ↗
• MalfunctionJul 24, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CARTRIDGE WAS DETACHED AND BROKEN. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588828 ↗
• MalfunctionJul 18, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE FINAL ESOPHAGUS-STOMACH ANASTOMOSIS USING THE COLLARD MODIFICATION, THE BLACK FIRING KNOB STOP PED MIDWAY. IT WAS NOTED THAT IT WAS POSSIBLE TO PULL BACK THE BLACK FIRING KNOB. ANOTHER NEW CARTRIDGE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542691 ↗
• MalfunctionJul 16, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER DURING A PROCEDURE, THE DEVICE PARTIALLY FIRED (DID NOT FIRE COMPLETELY TO THE DISTAL END). SUTURING WAS PERFORMED AS STAPLE LINE REPLACEMENT. SURGICAL TIME WAS EXTENDED BY 25 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 22517523 ↗
• MalfunctionJul 11, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN OPEN EXPLORATORY LAPAROTOMY, SMALL BOWEL RESECTION, AND COLON RESECTION, THE DEVICE HAD A STAPLE FORMATION ISSUE WHILE RESECTING THE RIGHT COLON. TO ADDRESS THE FAILED STAPLE LINE, THE SURGICAL TEAM PERFORMED A RESECTION AND RE-STAPLING AS AN ADDITIONAL INTERVENTION. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED.

  Patient problems: Tissue Breakdown

  MAUDE report 22482383 ↗
• MalfunctionJun 17, 2025Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BLACK PUSHER THUMB PIECE COULD BE MOVED. THE DEVICE CUT THE TISSUE BUT DID NOT STAPLE. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 22236719 ↗
• MalfunctionJun 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE OPEN STAPLER DID NOT FIRE. THE DEVICE WAS REPLACED WITH A NEW RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201543 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE USE OF THE DEVICE, THERE WERE ISSUES WITH STAPLE LINE LEAKS AFTER FIRING. AN ADDITIONAL SURGERY WAS REQUIRED AS AN INTERVENTION.

  Patient problems: Tissue Breakdown

  MAUDE report 22141239 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A GASTRODUODENAL PANCREATECTOMY INVOLVING THE RELOAD, THE PATIENT EXPERIENCED SEVERE HEMORRHAGIC SHOCK AND STAPLE LINE BLEEDING. THE PATIENT WAS READMITTED TO THE HOSPITAL AND REQUIRED ADDITIONAL SURGERY. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 22129007 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE, THE GIA10038S AND TWO GIA10038L STAPLERS WERE USED. A DAY AFTER THE SURGERY, BLEEDING FROM THE STAPLE LINE WAS OBSERVED, WHICH WAS IDENTIFIED AS A PRODUCT ISSUE AFTER FIRING. THIS COMPLICATION NECESSITATED AN ADDITIONAL SURGICAL INTERVENTION TO STOP THE BLEEDING. THE SURGEONS PERFORMED A RESECT AND RE-STAPLE PROCEDURE TO ADDRESS THE ISSUE. IT WAS NOTED THAT THE PATIENT WAS ADMITTED TO THE (ICU) INTENSIVE CASE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21033071 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY PROCEDURE, THE GIA10038S AND TWO GIA10038L STAPLERS WERE USED. A DAY AFTER THE SURGERY, BLEEDING FROM THE STAPLE LINE WAS OBSERVED, WHICH WAS IDENTIFIED AS A PRODUCT ISSUE AFTER FIRING. THIS COMPLICATION NECESSITATED AN ADDITIONAL SURGICAL INTERVENTION TO STOP THE BLEEDING. THE SURGEONS PERFORMED A RESECT AND RE-STAPLE PROCEDURE TO ADDRESS THE ISSUE. IT WAS NOTED THAT THE PATIENT WAS ADMITTED TO THE (ICU) INTENSIVE CASE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21025952 ↗
• MalfunctionDec 5, 2024Failure to Fire; Fail-Safe Problem; Failure to Fire; Fail-Safe Problem

  IT WAS REPORTED THAT DURING A WHIPPLE PROCEDURE, THE DEVICE EXPERIENCED FIRING ISSUES. THE INSTRUMENT DID NOT FIRE, AND THE WHITE FLAG INTERLOCK/KNIFE BLADE COVER WAS ALREADY ENGAGED, WHILE THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857101 ↗
• MalfunctionOct 10, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO RELOADS DID NOT FIRE. A NEW RELOAD WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 20418222 ↗
• MalfunctionOct 10, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWO RELOADS DID NOT FIRE. A NEW RELOAD WAS USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 20418095 ↗
• MalfunctionSep 10, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BLADE OF THE RELOAD WAS STUCK. A NEW RELOAD WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185195 ↗
• MalfunctionJun 28, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE STAPLER FAILED TO FIRE. IT WAS NOTED THAT THE WHITE FLAG WAS ENGAGED. THE RELOAD WAS REPLACED, BUT THE SAME ISSUES WERE OBSERVED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639208 ↗
• MalfunctionMay 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, THE DEVICE DID NOT FIRE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19394271 ↗
• MalfunctionApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, AT THE EXTRACORPOREAL RESECTION OF THE DESCENDING COLON, THE DEVICE WAS FIRED AND APPEARED TO DEHISCE IN THE MIDDLE OF THE STAPLE LINE. TO RESOLVE THE ISSUE, THE STAPLE LINE WAS RESECTED AND RE-STAPLED, AND ANOTHER OPEN STAPLER WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 19193644 ↗

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 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-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-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-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-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-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-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-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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT

…and 58 more.