GIA GIA8048SRecalls & reported problems

Summary

The FDA's MAUDE database contains 169 adverse event reports that list this exact device (DI 10884523007282), received between Apr 20, 2017 and May 14, 2026 — classified as 17 injuries, 152 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (83 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 169 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A RESECTION AND RIGHT ILEOCOLONIC ANASTOMOSIS ON OCCLUSION, WHEN USING THE SECOND REFILL, THE STAPLING LINE DID NOT GO ALL THE WAY TO THE END OF THE CLAMP. AN ADDITIONAL REFILL WAS GIVEN AFTER RINSING THE CLAMP AND AGAIN THE STAPLING LINE WAS INCOMPLETE. WITH A FOURTH REFILL, THE SURGEON WANTED TO CHANGE SIDES TO FINISH HIS CUT AND ANASTOMOSIS (FROM THE OPPOSITE END OF THE CUT) AND THE OPERATION THEN WENT WELL.

  Patient problems: Insufficient Information

  MAUDE report 25168639 ↗
• MalfunctionApr 8, 2026Failure to Cut; Fail-Safe Problem

  IT WAS REPORTED THAT DURING AN EXPLORATORY LAPAROTOMY, IN OPEN GASTRECTOMY, THE DEVICE FUNCTIONED PROPERLY DURING THE FIRST TWO FIRINGS. HOWEVER, ON THE THIRD FIRING, IT FAILED TO COMPLETELY SEVER THE TISSUE EVEN THOUGH THE STAPLES WERE COMPLETE. THE DEVICE WAS FLUSHED AND RELOADED, BUT THE BLADE REMAINED EXPOSED WHILE THE JAWS REMAINED OPEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820549 ↗
• MalfunctionNov 19, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PANCREATICODUODENECTOMY, THE INSTRUMENT DID NOT FIRE. THE BLACK PUSHER THUMB PIECE COULD NOT BE MOVED. ANOTHER DEVICE WAS USED WITHOUT ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597057 ↗
• MalfunctionSep 9, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A COLON RESECTION PROCEDURE, IN THE ANASTOMOSIS, THE BLACK FIRING KNOB OF THE DEVICE DID NOT ADVANCE. THE STAPLER COULD NOT BE FIRED AT ALL. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011102 ↗
• MalfunctionJul 29, 2025Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RELOAD DID NOT FIRE DURING SET-UP PRIOR TO USE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22648649 ↗
• MalfunctionJul 22, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE DID NOT FIRE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564864 ↗
• MalfunctionNov 21, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE FIRED AND CUT THE INTESTINAL TISSUE, BUT NO STAPLES WERE DEPLOYED. THE SECOND STAPLER DID NOT FIRE. TO RESOLVE THE ISSUE, MANUAL SUTURE WAS DONE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751893 ↗
• MalfunctionNov 21, 2024Failure to Fire; Mechanics Altered; Failure to Fire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE FIRED AND CUT THE INTESTINAL TISSUE, BUT NO STAPLES WERE DEPLOYED. THE SECOND STAPLER DID NOT FIRE. TO RESOLVE THE ISSUE, MANUAL SUTURE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tissue Breakdown

  MAUDE report 20751730 ↗
• MalfunctionNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LEFT COLON RESECTION, WHEN SETTING UP THE DEVICE, THE BLACK RELEASE BUTTON BROKE AFTER IT WAS TAKEN OUT OF THE PACKAGE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651733 ↗
• MalfunctionAug 15, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY, THE THREE PRE-LOADED OPEN STAPLER AND THREE ADDITIONAL RELOADS WERE STICKING IN THE SAME PLACE WHEN SLIDING THE PUSHER THUMB PIECE. THE SURGEON RECONSTRUCTED THE FAULT ON A CLEAN DEVICE, AND THE ISSUE WAS RESOLVED IN A FEW MINUTES BY OPENING A NEW DEVICE SO THE OPERATION WAS NOT DELAYED. THE SURGERY WAS COMPLETED BUT MULTIPLE DEVICES WERE NEEDED TO COMPLETE THE ANASTOMOSIS OF THE BOWEL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990701 ↗
• MalfunctionAug 5, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE COMPLETELY TO THE END. THE DEVICE PARTIALLY FIRED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911663 ↗
• InjuryJul 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF DIVISION OF COLON APPROXIMATION OF RECTAL STUMP. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AIR-CONTAINING COLLECTION, ABSCESS, LABS ABNORMAL FOR CREATININE, WBC, PURULENT FLUID, FISTULA, FEVER, ELECTROLYTE IMBALANCE, ANASTOMOSIS LEAK. POST-OPERATIVE PATIENT TREATMENT INCLUDED CT SCAN, HOSPITALIZATION, INTERVENTIONAL RADIOLOGY PROCEDURE, BIOPSY/ASPIRATION OF ABDOMEN DRAINAGE, ANTIBIOTICS, POTASSIUM SUPPLEMENTATION.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Electrolyte Imbalance; Fever; Fistula; Purulent Discharge; Unspecified Tissue Injury

  MAUDE report 19864724 ↗
• MalfunctionJul 25, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A CEPHALIC DUODENO PANCREATECTOMY, WHEN SETTING UP THE DEVICE, THE JAWS OF THE DEVICE WAS STUCK AND WOULD NOT OPEN. ANOTHER STAPLER FROM THE SAME LOT WAS OPENED AND HAD THE SAME ISSUE. ANOTHER DEVICE FROM A COMPETITOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19830981 ↗
• MalfunctionJul 25, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A CEPHALIC DUODENO PANCREATECTOMY, WHEN SETTING UP THE DEVICE, THE JAWS OF THE DEVICE WAS STUCK AND WOULD NOT OPEN. ANOTHER STAPLER FROM THE SAME LOT WAS OPENED AND HAD THE SAME ISSUE. ANOTHER DEVICE FROM A COMPETITOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19830940 ↗
• MalfunctionJul 12, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A PARTIAL RESECTION OF THE COLON DESCENDENS, THE SURGEON POSITIONED THE INSTRUMENT ON THE TISSUE, AND WANTED TO START FIRING, BUT UNABLE TO. SOME STAPLES WERE PUSHED, BUT THE PUSHER COULD NOT BE MOVED FORWARD OR BACKWARD ANYMORE. THE LEAD SURGEON ASKED THE ASSISTANT SURGEON TO FIRE THE DEVICE, BUT THE DEVICE STILL COULD NOT BE FIRED. A COMPLETELY NEW OPEN PRE-LOADED STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729905 ↗
• MalfunctionJun 25, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING RIGHT HEMICOLECTOMY, THE BLACK LEVER COULD NOT BE PUSHED DURING THE FIRING, SO THE FIRING COULD NOT BE DONE. A NEW STAPLER WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19607299 ↗
• MalfunctionJun 25, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A ROBOT-ASSISTED LAPAROSCOPIC RIGHT HEMICOLECTOMY, DURING ANASTOMOTIC OPERATION, THE INTESTINE WAS CLAMPED, BUT THE LEVER COULD NOT BE PUSHED AND THE FIRING COULD NOT BE DONE. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606675 ↗
• MalfunctionJun 21, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, 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 19586248 ↗
• MalfunctionJun 12, 2024Failure to Align; Fail-Safe Problem; Failure to Align; Fail-Safe Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RIGHT HEMICOLECTOMY, DURING COLONIC ANASTOMOSIS USING THE TWO FIRING METHOD, THE LOCK COVER OF THE KNIFE WAS ELEVATED WHEN THE PRODUCT WAS OPENED, SO THE DEVICE COULD NOT BE CLOSED. THE HINGE PIN COULD NOT BE SECURED IN POSITION AS USUAL AND THE WHITE FLAG INTERLOCK WAS ALREADY ENGAGED. ANOTHER DEVICE FROM ANOTHER LOT WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19519691 ↗
• MalfunctionMay 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN ABDOMINAL PROCEDURE, WHILE FIRING, THE DEVICE JAMMED/FROZE AFTER THE FIRST FEW STAPLES. THE SURGEON WAS UNABLE TO MOUNT THE PUSH BUTTON DESPITE NORMAL CONDITIONS OF USE. A NEW RELOAD WAS USED WITH THE SAME HANDLE, BUT THE SAME ISSUE OCCURRED. THE SURGEON REPLACED THE DEVICES AND USED A NEW STAPLER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19395942 ↗
• MalfunctionMay 23, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN COLECTOMY PROCEDURE, AT THE TIME OF COLON RESECTION, THE TWO OPEN STAPLERS DID NOT FIRE. A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387766 ↗
• MalfunctionMay 23, 2024Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A RESECTION OF THE SMALL BOWEL, THERE WERE SOME DIFFICULTIES EXPERIENCED WITH THE FIRING OF THE 2ND TO THE LAST RELOAD AND THE LAST RELOAD USED WAS NOT ABLE TO BE FIRED AT ALL, THE BLACK THUMB PIECE DID NOT MOVE AT ALL. THERE WAS TISSUE DAMAGE DUE TO THE ISSUE AS 10CM EXTRA RESECTION OF BOWEL WAS MADE WITH A NEW ANASTOMOSIS. ANOTHER DEVICE WAS USED FOR A NEW ANASTOMOSIS.

  Patient problems: Failure to Anastomose; Tissue Breakdown

  MAUDE report 19387744 ↗
• MalfunctionMay 23, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN COLECTOMY PROCEDURE, AT THE TIME OF COLON RESECTION, THE TWO OPEN STAPLERS DID NOT FIRE. A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387538 ↗
• MalfunctionMay 22, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN RIGHT COLON RESECTION, PREPARING TO TRANSECT THE COLON, THE OPEN STAPLER DID NOT FIRE. ANOTHER STAPLER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376041 ↗
• MalfunctionMay 16, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROTOMY SUBTOTAL GASTRIC-SPARING PANCREATICODUODENECTOMY, THE DEVICE DID NOT FIRE. IT WAS NOT POSSIBLE TO PUSH THE GEARING KNOB FORWARD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19336784 ↗

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-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-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-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-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-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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

…and 58 more.