GIA GIA10038SRecalls & reported problems

Summary

The FDA's MAUDE database contains 456 adverse event reports that list this exact device (DI 30884521031672), received between Sep 22, 2016 and Sep 21, 2026 — classified as 1 death, 63 injuries, 392 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (229 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 456 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Misfire; Firing Problem

  According to the reporter during a procedure using a manual stapler, the device was difficult to fire and the knife jammed while firing. Replaced the device of the same product to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841090 ↗
• InjuryMay 21, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STAPLER BECAME STUCK WHILE FIRING AND CAUSES STAPLES DEFORMATION AND NOT A REGULAR SHAPE. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT. ADDITIONALLY, POST-OPERATIVE HEMORRHAGE WAS REPORTED AND THE PATIENT WAS READMITTED TO THE OPERATING ROOM. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT, AND EXPERIENCED EXTENDED HOSPITALIZATION.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 25244240 ↗
• MalfunctionMay 18, 2026Failure to Fire

  IT WAS REPORTED THAT DURING PROCEDURE, THE INSTRUMENT DID NOT FIRE. TO ADDRESS THE ISSUE, THE RELOAD WAS REPLACED. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25203252 ↗
• MalfunctionApr 23, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLER PARTIAL FIRED DISTALLY. THE SURGEON MANUALLY REDID THE ANASTOMOSIS, AND SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT.

  Patient problems: Failure to Anastomose

  MAUDE report 24969098 ↗
• MalfunctionApr 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLE LINE WAS INCOMPLETE AFTER FIRING.

  Patient problems: Tissue Breakdown

  MAUDE report 24807659 ↗
• MalfunctionApr 3, 2026Mechanics Altered

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, THE DEVICE PERFORMED THE INCISION BUT FAILED TO DEPLOY ANY STAPLES. THIS ISSUE CAUSED THE PROCEDURE TO BE EXTENDED BY APPROXIMATELY 10 MINUTES. THE FAULTY DEVICE WAS REPLACED WITH ANOTHER OPEN STAPLER TO COMPLETE THE SUTURING, AND THE PROCEDURE WAS SUCCESSFULLY RESUMED.

  Patient problems: Tissue Breakdown

  MAUDE report 24775460 ↗
• MalfunctionJan 5, 2026Failure to Align; Packaging Problem

  ACCORDING TO THE REPORTER, IN AN OPEN PANCREATICODUODENECTOMY, DURING GASTRIC BODY TRANSECTION, THE TWO HALVES OF THE STAPLER WOULD NOT JOIN AND LOCK INTO PLACE AS USUAL AT THE HINGE PIN. THE STAPLE JAWS COULD NOT BE CLOSED. THE PACKAGING OF THE DEVICE WAS ALSO DAMAGED. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23954682 ↗
• MalfunctionDec 12, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER DURING AN OPEN PANCREATICODUODENECTOMY, WHEN ON THE RESECTION OF THE STOMACH, THE STAPLER PARTIALLY FIRED (THE FIRING COULD NOT BE COMPLETED TO THE DISTAL END). THE RESECTION WAS CONTINUED AGAIN USING A NEW STAPLER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796842 ↗
• MalfunctionNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A PARTIAL GASTRECTOMY, WHILE STAPLING THE GASTRIC, THERE WAS A COMPLETE STAPLE LINE DEHISCENCE WITH INTENSE CONTAMINATION OF THE PERITONEAL CAVITY. THIS RESULTED IN INFECTION.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 23566110 ↗
• MalfunctionNov 14, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE INSTRUMENT DID NOT FIRE AT ALL. THE SURGERY WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554505 ↗
• MalfunctionOct 17, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS NOT FIRING. 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 23321038 ↗
• MalfunctionSep 16, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE STAPLER DID NOT FIRE AS THE BLADE DID NOT GO UP. THE TRIGGER WAS STIFF AND COULD NOT BE SQUEEZE.

  Patient problems: Insufficient Information

  MAUDE report 23066326 ↗
• MalfunctionAug 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRE-OPERATIVELY, THE BLACK BUTTON WAS BROKEN. THE BROKEN PART DISENGAGED, BUT NO PIECES FELL INTO A PATIENT CAVITY. THE DEVICE WAS REPLACED WITH A COMPETITOR DEVICE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900259 ↗
• MalfunctionAug 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BLACK PUSH BUTTON FOR STAPLING AND CUTTING DETACHED FROM THE DEVICE, RENDERING THE PLIERS UNUSABLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22889001 ↗
• MalfunctionAug 6, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AN ATTEMPT WAS MADE TO FIRE, BUT THE BLACK FIRING KNOB DID NOT ADVANCE. THE FIRING COULD NOT BE DONE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731150 ↗
• 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 22542799 ↗
• 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 22236693 ↗
• MalfunctionJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE DEVICE IN A WHIPPLE OPERATION, THE STAPLE LINE DID NOT HOLD AND SUBSEQUENTLY OPENED UP AFTER FIRING. SUTURING WAS PERFORMED AS A REPLACEMENT FOR THE STAPLE LINE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tissue Breakdown

  MAUDE report 22236163 ↗
• 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 22141379 ↗
• MalfunctionJun 3, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN BLADDER COLON PROCEDURE, WHILE CUTTING THE TISSUE, THE CARTRIDGE BROKE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22136967 ↗
• MalfunctionMay 21, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN GASTRIC CANCER SURGERY, DURING SEPARATION OF THE GASTRIC TISSUE, THE BLACK PUSHER ROD COULD NOT BE PUSHED. A NEW OPEN STAPLER WAS USED TO RESOLVE THE ISSUE. AFTER THE SURGERY, THE SALES REP TRIED TO PUSH THE BLACK PUSHER ROD, BUT IT WAS STUCK AT FIRST AND IT REQUIRED A LOT OF FORCE TO PUSH IT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062448 ↗
• MalfunctionMay 2, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN ILEOSTOMY TAKEDOWN WITH PARTIAL BOWEL RESECTION, THE STAPLES WERE POORLY FORMED AND THE STAPLE LINE FELL APART. THE SURGERY EXPERIENCED A DELAY WHILE OBTAINING AND OPENING A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21954831 ↗
• MalfunctionApr 30, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A COLECTOMY, THERE WERE FIRING ISSUES DURING A PROCEDURE INVOLVING THE TWO OPEN STAPLER. THE DEVICES EXPERIENCED PARTIAL FIRING, NOT COMPLETING TO THE DISTAL END. THE DEVICES WERE 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 21933430 ↗
• MalfunctionApr 24, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, THE STAPLER WAS DIFFICULT TO CLOSE ON THE TARGET TISSUE AND COULD NOT BE LOCKED MULTIPLE TIMES, PREVENTING IT FROM FIRING. THE STAPLER WAS REPLACED WITH ANOTHER OF THE SAME MODEL, WHICH FUNCTIONED WITHOUT ISSUE, ALLOWING THE OPERATION TO CONTINUE AS NORMAL.

  Patient problems: Insufficient Information

  MAUDE report 21905384 ↗
• MalfunctionApr 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL PERINEAL RESECTION, THE HANDLE OF THE STAPLER CAME OFF BEFORE IT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878785 ↗

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-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-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-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-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-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-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-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-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-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT

…and 58 more.