Endo GIA EGIARADXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 10884521141742), received between Aug 7, 2017 and Feb 2, 2026 — classified as 8 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (30 reports).

1 other recall cover devices cleared under the same FDA submission (K102291, K132493); 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, AFTER FIRING THE RELOAD, THE TISSUE REOPENED, AND SUTURING WAS REQUIRED AS A STAPLE LINE REPLACEMENT. THE SURGICAL TIME WAS EXTENDED BY APPROXIMATELY 30 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 24240238 ↗
• MalfunctionAug 28, 2025Retraction Problem; Insufficient Device Problem Information; Retraction Problem; Insufficient Device Problem Information

  PRODUCT WAS RETURNED WITHOUT ACCOMPANYING INFORMATION. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THERE WAS AN INCOMPLETE RETRACTION.

  Patient problems: Insufficient Information

  MAUDE report 22915871 ↗
• MalfunctionAug 7, 2025Misfire; Firing Problem; Misfire; Firing Problem

  IT WAS REPORTED THAT DURING THE LOWER ANTERIOR RESECTION, THERE WERE DIFFICULTIES IN FIRING AND THE INSTRUMENT MADE A STRANGE NOISE. SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. STAPLE PUSHERS WERE VISIBLE ALONG ONE-THIRD OF THE CARTRIDGE, STARTING FROM THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22744540 ↗
• MalfunctionJul 22, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, AT THE TIME OF ENTERING THE CAVITY, THE JAW OF THE RADIAL REFILL REMAINED CLOSED AND COULD NOT BE OPENED. THE DEVICE WAS REPLACED WITH ANOTHER RADIAL REFILL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565910 ↗
• MalfunctionSep 10, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLER COULD NOT FULLY CATCH THE HANDLE, CLOSING IT COMPLETELY. ONLY CLIPPED HALF OF THE FABRIC. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181185 ↗
• MalfunctionSep 3, 2024Misfire; Adverse Event Without Identified Device or Use Problem; Misfire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD PRESENTED FAILURE TO STAPLE THE TISSUE, IT DID NOT FULLY STAPLE COMPLETELY, AND THE STAPLE CAME LOOSE IN HALF. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20131214 ↗
• MalfunctionJan 19, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN LOWER ANTERIOR RESECTION, IN RESECTION OF THE RECTUM, THE DEVICE DID NOT FIRE PROPERLY AS THE STAPLE LINE WAS DISTALLY INCOMPLETE. ADDITIONALLY, THE STAPLE FORMATION WAS ALSO INCOMPLETE. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED.

  Patient problems: Tissue Breakdown

  MAUDE report 18546090 ↗
• MalfunctionDec 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ULTRA LOWER ANTERIOR RESECTION PROCEDURE, AT THE TIME OF RECTUM RESECTION, THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE AFTER PRESSING THE GREEN BUTTON. THE SURGEON MANUALLY RESECTED AND SUTURED THE TISSUE TO RESOLVE THE ISSUE. THE HANDLE WAS THEN USED AND WAS ABLE TO WORK WITH OTHER RELOADS. THE PROCEDURE WAS CONVERTED INTO AN OPEN PROCEDURE UNRELATED TO THE DEVICE PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267886 ↗
• MalfunctionSep 21, 2023Failure to Fire; Component or Accessory Incompatibility; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC LEFT HEMICOLECTOMY, WHILE IN THE LARGE INTESTINE, THE DEVICE WAS PREPARED FOR STAPLING BUT THE DEVICE DID NOT WORK. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE BUT THE DEVICE DID NOT FIRE. THE DEVICE WAS CLOGGED. THE DEVICE WAS STUCK. THE NURSE FIRST CHANGED THE HANDLE, BUT THE STAPLE DID NOT FIX SO THE NURSE CHANGED THE HANDLE AND RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17789369 ↗
• MalfunctionJul 20, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A COLECTOMY, THE SURGEON WAS ABLE TO PRESS THE THE GREEN BUTTON AND SQUEEZE THE HANDLE BUT THE STAPLER WAS UNABLE TO FIRE. IT WAS NOT POSSIBLE TO SHOOT SINCE IT FELT STUCK AND DID NOT ADVANCE. IT WAS ALSO MENTIONED THAT THE SECOND HANDLE AND RELOAD HAD NO ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 17358530 ↗
• MalfunctionJun 29, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTOSIGMOIDECTOMY PROCEDURE, AT THE BEGINNING OF THE PROCEDURE, THE SHELL WAS DIFFICULT TO CLOSED BUT EVENTUALLY CLOSED AND THE RELOAD WAS LOCKED AND DID NOT RUN. A NEW RELOAD WITH A DIFFERENT MODEL WAS USED TO RESOLVE THE ISSUE, ALONG WITH THE SAME SHELL, ADAPTER AND SHELL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231322 ↗
• MalfunctionApr 25, 2023Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOWER ANTERIOR RESECTION CONVERTED TO A PLANNED OPEN PROCEDURE, INTO THE LOW PELVIS ABOUT EIGHT CENTIMETER FROM THE RECTUM, LOCATED ON OR NEAR THE THICK TUMOR TISSUE, THE RADIAL RELOAD FIRED A COMPLETE STAPLE LINE BUT DID NOT TRANSECT THE TISSUE. TO RESOLVE THE ISSUE, A DEVICE FROM ANOTHER MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809571 ↗
• MalfunctionApr 6, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING AN OPEN PERINEAL RECTO SIGMOIDECTOMY PROCEDURE, AT THE TIME OF STAPLING THE SIGMOID COLON, THE STAPLES OF THE SECOND RELOAD HAD POOR FORMATION AND THE STAPLE LINE WAS CENTRALLY AND DISTALLY INCOMPLETE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16691554 ↗
• MalfunctionMay 2, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO ASSISTED THORACOSCOPIC SURGERY, WHILE ON THE RESECTION OF THE LUNG TISSUE, THE STAPLER WAS UNABLE TO FIRE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. AN ADDITIONAL RELOAD WAS OPENED AND LOADED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14258583 ↗
• MalfunctionMar 23, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC FRONT LOW COLORECTAL RESECTION, WHILE THE LOW COLORECTAL WAS BEING CUT, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE HE ISSUE. THERE WAS O PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863129 ↗
• MalfunctionSep 1, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING RESECTION IN LOWER GASTROINTESTINAL PROCEDURE, AFTER GRASPING THE TISSUE AND PRESSING THE GREEN BUTTON, THE SURGEON CANNOT SQUEEZED THE HANDLE. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408000 ↗
• InjuryMay 6, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING THE RESECTION OF THE RECTUM ON A COLON SIGMOIDECTOMY WITH EXPLORATORY SURGERY AND TWO COLOSTOMIES, THE STAPLER FIRED BUT STAPLE LINE WAS INCOMPLETE PROXIMALLY. IT WAS STATED THAT THE BLADE DID NOT ADVANCE TO MORE THAN 1CM. THE MALFUNCTION OCCURRED ON TWO RELOAD. THE SURGEON HAD TO FINISH THE RESECTION WITH MANUAL SUTURE. THE SURGICAL TIME WAS EXTENDED TO 30 MINUTES OR MORE SINCE THE SURGEON HAD TO PERFORM MANUAL SUTURING TO FIX THE STAPLE LINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11783695 ↗
• InjuryMar 29, 2021Misfire; Failure to Form Staple; Detachment of Device or Device Component; Misfire; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LEFT COLECTOMY, WHEN PERFORMING ANASTOMOSIS, THE DEVICE DID NOT CUT OR SHOOT PROPERLY. POOR STAPLE FORMATION WAS OBSERVED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581721 ↗
• MalfunctionNov 6, 2020Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING COLON RESECTION ON AN OPEN LOW STRAIGHT RESECTION, THE HANDLE WAS ABLE TO RECOGNIZE THE HANDLE, BUT THE BLADE IN THE LOAD DID NOT ADVANCE, AND THE STAPLES DID NOT COME OUT. THE RELOAD WAS EXCHANGED TO ANOTHER EQUAL DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10805335 ↗
• MalfunctionMay 28, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ASSISTED BOWEL RESECTION, THE STAPLER MISFIRED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10097098 ↗
• InjuryMar 30, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A COLOSTOMY PROCEDURE, WHILE WORKING ON THE TISSUE, THERE WAS A PROBLEM AFTER FIRING THE RELOAD. THERE WERE RELOADS THAT DID NOT CLOSE OR FORM. IT WAS NECESSARY TO RESECT ADDITIONAL RESECTION DUE TO POOR STAPLE FORMATION. THE USED ANOTHER/NEW RELOAD TO FINISH THE PROCEDURE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9901681 ↗
• MalfunctionMar 5, 2020Break; Difficult to Open or Close; Break; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC RECTOSIGMOIDECTOMY PROCEDURE, AFTER POSITIONING AND CLOSING THE LOAD A TRIGGER HAS BEEN TAKEN, AT THIS INSTANT HEARING A STRONG SNAP THAT BELIEVES TO BE OF THE LOAD AND PRESENCE OF OPEN CLAMPS. THERE WAS THE NEED TO CHANGE THE LOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9792612 ↗
• InjuryFeb 6, 2020Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST HEMICOLECTOMY, PATIENT PRESENTED SOME PAIN AND FEVER. IT WAS STATED THAT THE PATIENT WENT BACK TO SURGERY AND EXTEND HOSPITAL STAY.

  Patient problems: Fever; No Code Available; Pain

  MAUDE report 9677849 ↗
• MalfunctionNov 6, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLORECTAL SURGERY, WHEN STAPLING, THE STAPLER DID NOT ADVANCE. THE RADIAL RELOADS FAILED AND DID NOT FIRE TWICE IN A ROW. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE STAPLER TRIGGER WAS INTERNALLY BROKEN. THE SURGEON USED OTHER STAPLER WITH TRI-STAPLE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284219 ↗
• MalfunctionNov 6, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLORECTAL SURGERY, WHEN STAPLING, THE STAPLER DID NOT ADVANCE. THE RADIAL RELOADS FAILED AND DID NOT FIRE TWICE IN A ROW. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE STAPLER TRIGGER WAS INTERNALLY BROKEN. THE SURGEON USED OTHER STAPLER WITH TRI-STAPLE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9284214 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102291, K132493. One submission often covers many models, so check the product and lot details in each record.

• Z-0908-2018 · Sep 15, 2017 · Terminated
  Endo GIA" Radial Reload with Tri-Staple" Technology The Endo GIA radial reloads with Tri-Staple Technology have application in open or minimally invasive general abdominal, gyne