Tri-Staple 2.0 SIG60CTAVMRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521543690), received between Mar 12, 2018 and Sep 23, 2026 — classified as 7 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (8 reports).

14 other recalls cover devices cleared under the same FDA submission (K160176); 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Fire

  According to the reporter, during a procedure, two handles could not be squeezed and the device failed to fire despite the jaw being completely closed, after which manual suturing was performed as a staple line replacement. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864537 ↗
• MalfunctionApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADJUSTABLE GASTRIC BAND AND SUBCUTANEOUS PORT REMOVAL, AS WELL AS A LAPAROSCOPIC PARTIAL GASTRECTOMY ROUX-EN-Y WITH INTRAOPERATIVE ENDOSCOPY, AFTER FIRING THE PURPLE RELOAD, BLEEDING OCCURRED. WHEN THE REMNANT STOMACH WAS CREATED, AFTER 15 MINUTES OF FIRING A PURPLE REINFORCEMENT RELOAD, THERE WAS STAPLE LINE BLEEDING. ADDITIONALLY, FROM THE STAPLE LINE AT THE JEJUNUM AFTER 20 MINUTES OF FIRING A CURVED TIP TAN LOAD, THE SAME ISSUE OCCURRED. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE SURGICAL PROCEDURE WAS EXTENDED BY ABOUT 30 MINUTES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 24841281 ↗
• MalfunctionJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY OF A SEGMENTAL SMALL BOWEL RESECTION, THERE WERE ISSUES WITH THE DEVICES, RESULTING IN AN ANAS TOMOTIC LEAK 13 DAYS AFTER SURGERY. IT WAS NOTED THAT THE PATIENT HAD EMERGENT SURGERY AND NON ELECTIVE.

  Patient problems: Failure to Anastomose

  MAUDE report 22575543 ↗
• MalfunctionJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY OF A SEGMENTAL SMALL BOWEL RESECTION, THERE WERE ISSUES WITH THE DEVICES, RESULTING IN AN ANAS TOMOTIC LEAK 13 DAYS AFTER SURGERY. IT WAS NOTED THAT THE PATIENT HAD EMERGENT SURGERY AND NON ELECTIVE.

  Patient problems: Failure to Anastomose

  MAUDE report 22575405 ↗
• MalfunctionJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY OF A SEGMENTAL SMALL BOWEL RESECTION, THERE WERE ISSUES WITH THE DEVICES, RESULTING IN AN ANASTOMOTIC LEAK 13 DAYS AFTER SURGERY. IT WAS NOTED THAT THE PATIENT HAD EMERGENT SURGERY AND NON-ELECTIVE.

  Patient problems: Failure to Anastomose

  MAUDE report 22575362 ↗
• MalfunctionDec 13, 2024Misfire; Expulsion; Misfire; Expulsion

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE RELOAD WAS DEFECTIVE. THE RELOAD APPEARED TO HAVE BEEN ALREADY FIRED WHEN OPENED FR OM THE PACKAGING. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S EVALUATION FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922341 ↗
• MalfunctionAug 9, 2024Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE HANDPIECE OPENED AND CLOSED OUTSIDE THE PATIENT WITH NO ISSUE, BUT DID NOT FIRE WHEN THE SURGEON ACTIVATED IT, AND STRUGGLED TO OPEN THE JAW AGAIN INSIDE THE PATIENT. THE USER HAD TO REPLACE AND OPEN A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 19955569 ↗
• MalfunctionJun 28, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE GASTRIC BYPASS SURGERY, THE STAPLE LINE WAS INCOMPLETE. IT WAS ALSO NOTED THAT THERE WAS METHYLENE BLUE FILTRATION. MANUAL SUTURING WAS PREFORMED TO FIX THE STAPLE LINE. THE SURGICAL TIME WAS EXTENDED FOR ABOUT 15 MINUTES AS A RESULT.

  Patient problems: Tissue Breakdown

  MAUDE report 19638353 ↗
• MalfunctionJun 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A LAPAROSCOPIC GASTRIC BYPASS ON THE STOMACH AND INTESTINE, THE PATIENT HAD DIGESTIVE BLEEDING. THE ISSUE OCCURRED ON THREE RELOADS. THE DIGESTIVE BLEEDING WAS MANAGED BY NON-HOSPITALIZED OBSERVATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19495316 ↗
• MalfunctionJun 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE PATIENT EXPERIENCED GASTRIC BLEEDING FOLLOWING THE USE OF 3 RELOADS. ONLY MEDICAL OBSERVATION WAS CONDUCTED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19490114 ↗
• MalfunctionJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON POST OPERATIVE LAPAROSCOPIC GASTRIC BYPASS, THE PATIENT HAD DIGESTIVE BLEEDING AFTER THE THREE RELOADS WERE APPLIED ON THE STOMACH AND INTESTINE. THE PATIENT WAS UNDER OBSERVATION AS A RESULT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19478812 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, FOLLOWING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE OF THE STOMACH AND INTESTINE, THE PATIENT HAD DIGESTIVE BLEEDING. THE ISSUE OCCURRED ON THREE RELOADS. THE PATIENT UNDERWENT ANOTHER PROCEDURE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 19478120 ↗
• MalfunctionMay 20, 2024Misfire; Failure to Fire; Insufficient Device Problem Information; Misfire; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHILE STAPLING A FISTULA, THE FORCEPS CLOSE. BUT, IT DID NOT SHACKLE (FIRE). A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19356482 ↗
• MalfunctionMar 24, 2023Misfire; Device Displays Incorrect Message; Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PANCREATICODUODENECTOMY, WHEN CUTTING THE PANCREATIC PARENCHYMA, THE FIRING STOPPED MIDWAY AND STOPPED MOVING HALFWAY. A FORCED RESTART WAS PERFORMED WITH THE GREEN BUTTON. WHEN THE CARTRIDGE WAS CHECKED, IT WAS DUE TO THE EXCESSIVE FORCE. AFTER THAT, ANOTHER POWER HANDLE AND RELOAD ARE TAKEN OUT TO COMPLETE THE FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16612972 ↗
• MalfunctionJan 24, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ATRIAL APPENDAGE, WHEN TRYING TO STAPLE THE HEART EAR, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT COULD NOT SQUEEZE THE HANDLE. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16232824 ↗
• MalfunctionDec 8, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN OPEN CYSTECTOMY, IN DIVISION OF VESSELS, THE FIRST HANDLE AND RELOAD WERE APPLIED OVER THE VESSEL TO BE STAPLED. WHEN THE GREEN BUTTON WAS PRESSED, THE HANDLE ADVANCED BUT WHEN SQUEEZED THE RELOAD WOULD NOT FIRE. ANOTHER RELOAD WAS TRIED, THEN ANOTHER HANDLE THEN OTHER RELOADS. ALL FOUR RELOADS COULD NOT BE FIRED ON BOTH HANDLES. THE STAPLERS COULD BE ARMED, BUT THE RELOAD WOULD NOT ADVANCE WHEN THE HANDLE WAS SQUEEZED. THE SURGEON USED SUTURE TO PROVIDE LIGATION AND PROCEEDED WITH THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15939127 ↗
• InjuryJun 14, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HIGH ANTERIOR RESECTION, THE IMV WAS STAPLED FIRST WITH THE 60 MILLIMETER VASCULAR RELOAD AND THEN FOLLOWED BY IMA WITH ANOTHER 60 MILLIMETER VASCULAR RELOAD, THERE WAS POOR STAPLE FORMATION THAT DID NOT DELIVER EFFECTIVE HEMOSTASIS. THE DEVICE WAS FIRED OVER THE IMV AND THE STAPLE LINE WAS OOZING AND ACTIVELY BLEEDING IN SOME AREAS. CLIPS WERE USED TO SECURE THE STAPLE LINE. THE SAME STAPLE RELOAD WITH A DIFFERENT LOT NUMBER WAS FIRED ON THE IMA AND HAD THE SAME RESULT, LESS BLEEDING BUT OOZING. CLIPS WERE APPLIED AGAIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 14685742 ↗
• InjuryJun 10, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC HIGH ANTERIOR RESECTION, THE IMV WAS STAPLED FIRST WITH THE 60 MILLIMETER VASCULAR RELOAD AND THEN FOLLOWED BY IMA WITH ANOTHER 60 MILLIMETER VASCULAR RELOAD, THERE WAS POOR STAPLE FORMATION THAT DID NOT DELIVER EFFECTIVE HEMOSTASIS. THE DEVICE WAS FIRED OVER THE IMV AND THE STAPLE LINE WAS OOZING AND ACTIVELY BLEEDING IN SOME AREAS. CLIPS WERE USED TO SECURE THE STAPLE LINE. THE SAME STAPLE RELOAD WITH A DIFFERENT LOT NUMBER WAS FIRED ON THE IMA AND HAD THE SAME RESULT, LESS BLEEDING BUT OOZING. CLIPS WERE APPLIED AGAIN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 14658439 ↗
• MalfunctionApr 18, 2022Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC LOW ANTERIOR RESECTION, WHEN ATTEMPTING TO FIRE ON A THICK, SCARRED TISSUE, A LOUD CLUNK WAS HEARD AND TWO HANDLES WERE UNABLE TO FIRE. THE JAWS LOCKED ON TISSUE. THE SURGERY WAS DELAYED AS A RESULT. ANOTHER HANDLE AND A BLACK RELOAD WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136578 ↗
• InjuryFeb 7, 2022Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING STAPLING OF THE INFERIOR PULMONARY VEIN IN A THORACIC SURGERY, THE DEVICE FAILED TO STAPLE THE CENTRAL PART OF THE INFERIOR PULMONARY VEIN. SURGEON HAD TO CLAMP THE VEIN TO SUTURE IT MANUALLY. THE ISSUE LED TO A 200ML BLOOD LOSS BEFORE BEING ABLE TO SUTURE THE VEIN MANUALLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 13477208 ↗
• InjuryNov 23, 2020Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SPLENECTOMY, ON THE DEPOSITION OF THE SPLEEN VESSELS, THE ARTERY AND VEIN WERE REMOVED WITH A MAGAZINE WITHOUT TRACTION, THE INSTRUMENT COULD BE FIRED COMPLETELY, THERE WAS POOR STAPLE FORMATION, THE STAPLE LINE WAS INCOMPLETE CENTRALLY, AFTER OPENING THE RELOAD, BOTH VESSEL STUMPS WERE PARTIALLY OPEN AS THE STAPLE LINE OPENED UP AND HAD TO BE OVERSTITCHED. THERE WAS TISSUE DAMAGE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10886746 ↗
• MalfunctionApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A ROUX-EN-Y GASTRIC BYPASS, THERE WAS SWELLING AT THE JEJUNOJEJUNOSTOMY STEMMING FROM THE PRIMARY DIAGNOSIS RELATED TO THE HANDLE AND RELOAD. NO ACTION WAS NEEDED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Swelling

  MAUDE report 9947704 ↗
• MalfunctionApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, ON A ROUX-EN-Y GASTRIC BYPASS, THERE WAS SWELLING AT THE JEJUNOJEJUNOSTOMY STEMMING FROM THE PRIMARY DIAGNOSIS RELATED TO THE HANDLE AND RELOAD. NO ACTION WAS NEEDED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Swelling

  MAUDE report 9947698 ↗
• MalfunctionMar 25, 2020Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, WHEN CREATING THE DUODENOILEOSTOMY DURING A LAPAROSCOPIC DUODENAL SWITCH, THE SURGEON FIRED THE FULL STAPLE RELOADS BUT NOTED THAT SOME STAPLES WERE AT THE TIP OF THE RELOAD AND DID NOT CRIMP AND THE LEGS WERE STILL STRAIGHT. THE SURGEON INSPECTED THE STAPLE AND PERFORMED A LEAK TEST TO CONFIRM THAT THE STAPLE LINE WAS SECURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876765 ↗
• InjuryJul 25, 2019Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON WAS NOT ABLE TO PRESS THE GREEN BUTTON BUT WAS ABLE TO SQUEEZE THE HANDLE. IT WAS ALSO REPORTED THAT THE HANDLE AND RELOAD WOULD NOT CLAMP DOWN ON TISSUE WHEN ARTICULATED. ANOTHER HANDLE WAS OPENED BUT HAD THE SAME ISSUE. ANOTHER RELOAD FROM A DIFFERENT MANUFACTURER WAS USED TO COMPLETE THE PROCEDURE. THE SURGICAL PROCEDURE WAS EXTENDED FOR 90 MINUTES AND A TEMPORARY DIVERTING ILEOSTOMY WAS PROVIDED BY THE SURGEON.

  Patient problems: No Code Available; No Information

  MAUDE report 8827968 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160176. One submission often covers many models, so check the product and lot details in each record.

• Z-1228-2023 · Jan 25, 2023 · Open, Classified
  Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1237-2018 · Dec 13, 2017 · Terminated
  Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Sta