Endo GIA Ultra EGIAUSHORTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3,011 adverse event reports that list this exact device (DI 10884523003536), received between Mar 28, 2017 and Sep 28, 2026 — classified as 2 deaths, 150 injuries, 2,859 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (1,818 reports).

73 other recalls cover devices cleared under the same FDA submission (K111825); 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 3,011 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Failure to Fire

  Patient problems: Tissue Breakdown

  MAUDE report 50923240 ↗
• MalfunctionSep 23, 2026Misfire

  Patient problems: Insufficient Information

  MAUDE report 50863024 ↗
• MalfunctionSep 18, 2026Break; Difficult to Open or Close

  According to the reporter, during a laparoscopic distal pancreatectomy, the handle/trigger was damaged prior to patient use. Although the handle was squeezed, the cartridge jaws were unable to close on the tissue. The jaws could not be closed, and the handle returned to its original position. It was noted that the issue occurred on three handles. A new handle was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819624 ↗
• MalfunctionSep 18, 2026Break; Difficult to Open or Close

  According to the reporter, during a laparoscopic distal pancreatectomy, the handle/trigger was damaged prior to patient use. Although the handle was squeezed, the cartridge jaws were unable to close on the tissue. The jaws could not be closed, and the handle returned to its original position. It was noted that the issue occurred on three handles. A new handle was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819557 ↗
• MalfunctionAug 31, 2026Break; Firing Problem

  Patient problems: Insufficient Information

  MAUDE report 50531411 ↗
• MalfunctionAug 31, 2026Firing Problem

  Patient problems: Insufficient Information

  MAUDE report 50531273 ↗
• MalfunctionAug 26, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461129 ↗
• MalfunctionAug 26, 2026Failure to Fire

  According to the reporter, during a gastrointestinal surgery, while on gastrointestinal tract, the firing could not be performed at all. The handle and reload were replaced with new ones to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50446201 ↗
• MalfunctionAug 25, 2026Break; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438146 ↗
• MalfunctionAug 25, 2026Human-Device Interface Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435301 ↗
• MalfunctionAug 21, 2026Failure to Fire; Difficult to Open or Close; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374686 ↗
• MalfunctionAug 13, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231937 ↗
• MalfunctionAug 12, 2026Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50218585 ↗
• MalfunctionAug 6, 2026Device Slipped; Misfire

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

  MAUDE report 50160277 ↗
• MalfunctionJul 30, 2026Break; Component or Accessory Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50090702 ↗
• MalfunctionJul 13, 2026Failure to Fire

  ACCORDING TO THE REPORTER DURING PULMONARY RESECTION ON THE PULMONARY PARENCHYMA, THE RELOAD PREFIRED AND FIRING COULD NOT BE COMPLETED. ANOTHER HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25807855 ↗
• MalfunctionJul 1, 2026Break; Device Slipped

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) LOBECTOMY, THE STAPLER HAD A RELOAD MOUNTED BUT THE GREEN SAFETY BUTTON COULD BE PRESSED AND THE HANDLE COULD BE SQUEEZED BUT THE HANDLE RAN IDLE AND HAD NO RESISTANCE, SO THE STAPLER DID NOT FIRE. THE HANDLE WAS REPLACED TO RESOLVE THE ISSUE. IT WAS NOTED THAT THERE WAS A SLIGHT DELAY IN THE SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND SHEARED FIRING RACK TEETH DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674349 ↗
• MalfunctionJun 25, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A PANCREATIC RESECTION PROCEDURE, THE FIRING STOPPED WHEN THE HANDLE WAS SQUEEZED, IT DID NOT ADVANCE AT ALL AND FIRING WAS ALMOST IMPOSSIBLE, SO ITS USE WAS DISCONTINUED. IT WAS ALSO NOTED THAT THE KNIFE BLADE WAS PULLED BACK. A NEW HANDLE AND CARTRIDGE WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25618051 ↗
• MalfunctionMay 5, 2026Failure to Fire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A WEDGE RESECTION, WHEN FIRING THE DEVICE, THE SURGEON HEARD A LOUD CRACKING NOISE. THE SURGEON WENT TO REPURPOSE THE RELOAD ON THE TISSUE, BUT THE DEVICE COULD NOT BE FIRED. THE SURGEON REPORTED THAT THERE WAS TOO MUCH TISSUE BETWEEN THE JAWS. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082233 ↗
• MalfunctionApr 16, 2026Difficult to Open or Close; Noise, Audible

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, WHILE ATTEMPTING TO GRASP TISSUE WITH THE STAPLER, THE INSTRUMENT JAW DID NOT FULLY CLOSE AND THE HANDLE PRESENTED UNUSUAL RESISTANCE WHEN ATTEMPTING TO ACTUATE IT. UPON APPLYING ADDITIONAL FORCE TO COMPLETE THE CLOSURE, THE USER REPORTED HEARING AN INTERNAL SOUND CONSISTENT WITH A POSSIBLE FRACTURE OF A COMPONENT INSIDE THE INSTRUMENT. THE USER THEN ATTEMPTED TO PERFORM ANOTHER TISSUE GRASP ON THINNER TISSUE; HOWEVER, THE STAPLER COULD NO LONGER BE ACTUATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902771 ↗
• MalfunctionApr 11, 2026Failure to Fire

  IT WAS REPORTED THAT DURING USE OF THE STAPLER, THE HANDLE FAILED TO FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE, AND THE DEVICE JAMMED. THE DEVICE WAS REPLACED BY USING ANOTHER NEW HANDLE AND RELOAD WITH THE SAME LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24849063 ↗
• MalfunctionApr 8, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE USER WAS ABLE TO PRESS THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED, THE FIRING COULD NOT BE DONE AT ALL. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. THE PRODUCT WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24819358 ↗
• MalfunctionApr 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC PARTIAL LUNG RESECTION, THERE WERE NO PROBLEMS WITH THE OPENING AND CLOSING CHECK DURING SETUP. AFTER CLAMPING THE TISSUE WITH THE JAW, IT WAS SET TO FIRING MODE AND WHEN ATTEMPTING TO START FIRING, THE HANDLE DID NOT MOVE, THE FIRING COULD NOT BE DONE AT ALL. ADDITIONALLY, IT WAS CONFIRMED THAT A STAPLE WAS SLIGHTLY PROTRUDING AT THE BASE. THE HANDLE AND THE CARTRIDGE WERE BOTH REPLACED, AND NEW PRODUCTS WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 24808340 ↗
• MalfunctionApr 7, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A DUODENAL STENOSIS GASTROJEJUNOSTOMY, AFTER THE DEVICE WAS FIRED 2-3 TIMES, THE HANDLE COULD NO LONGER MOVE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801594 ↗
• MalfunctionApr 3, 2026Failure to Fire; Noise, Audible

  IT WAS REPORTED THAT DURING A UNIPORTAL THORACOSCOPIC LOBECTOMY, WHEN TRANSECTING THE LUNG LOBE, AFTER FIRING AND PULLING THE HANDLE FULLY BACK, A LOUD CRACKING SOUND WAS HEARD, AND AN ATTEMPT TO FIRE THE NEXT CARTRIDGE WAS UNSUCCESSFUL. THE STAPLER COULD NOT BE FIRED, AND THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. THE DEVICE WAS REPLACED WITH A NEW MANUAL HANDLE TO COMPLETE THE PROCEDURE, AND THE PROCEDURE PROCEEDED SMOOTHLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781239 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111825. 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 tra
• 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-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-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-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-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-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-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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT

…and 58 more.