Tri-Staple 2.0 SIGC60VMRecalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10884521543560), received between Nov 21, 2017 and Mar 18, 2025 — classified as 11 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (9 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 16, 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.

• MalfunctionMar 18, 2025Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER FIRING, THE TISSUE WAS NOT CUT AT ALL BUT STAPLED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21634010 ↗
• MalfunctionSep 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE, ONE OF THE CARTRIDGE WAS NOT ABLE TO FIRE. IT WAS ALSO MENTIONED THAT THE OTHER CARTRIDGE DID NOT WORK. A NEW LOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687583 ↗
• MalfunctionSep 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SLEEVE, ONE OF THE CARTRIDGE WAS NOT ABLE TO FIRE. IT WAS ALSO MENTIONED THAT THE OTHER CARTRIDGE DID NOT WORK. A NEW LOAD WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17687532 ↗
• MalfunctionAug 11, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE, WHILE TRANSECTING THE STOMACH, THE FIRST 2 RELOAD WOULD NOT FULLY GO INTO THE LOADING UNIT, SO IT WAS NOT TRIED FOR FIRING. THE USER FELT LIKE SOMETHING WITH BLOCKING IT FROM FULLY SEATING. THE THIRD RELOAD TRIED WAS FROM THE SAME BOX, IT WAS LOADED, BUT WOULD NOT FIRE OR DEPLOY THE BLADE. THE FOURTH RELOAD WITH SAME ISSUE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE WITH THE SAME HANDLE AND ADAPTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515809 ↗
• MalfunctionAug 11, 2023Failure to Fire; Component or Accessory Incompatibility; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE, WHILE TRANSECTING THE STOMACH, THE FIRST 2 RELOAD WOULD NOT FULLY GO INTO THE LOADING UNIT, SO IT WAS NOT TRIED FOR FIRING. THE USER FELT LIKE SOMETHING WITH BLOCKING IT FROM FULLY SEATING. THE THIRD RELOAD TRIED WAS FROM THE SAME BOX, IT WAS LOADED, BUT WOULD NOT FIRE OR DEPLOY THE BLADE. THE FOURTH RELOAD HAD THE SAME ISSUE WITH THE FIRST TWO RELOADS WHEREIN IT COULD NOT BE LOADED INTO THE HANDLE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE WITH THE SAME HANDLE AND ADAPTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515808 ↗
• MalfunctionJun 12, 2023Failure to Fire; Component or Accessory Incompatibility; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE PROCEDURE, WHILE TRANSECTING THE STOMACH, THE FIRST TWO RELOAD WOULD NOT FULLY GO INTO THE LOADING UNIT, SO IT WAS NOT TRIED FOR FIRING. THE USER FELT LIKE SOMETHING WITH BLOCKING IT FROM FULLY SEATING. THE THIRD RELOAD TRIED WAS FROM THE SAME BOX, IT WAS LOADED, BUT WOULD NOT FIRE OR DEPLOY THE BLADE. THE FOURTH RELOAD WITH SAME ISSUE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE WITH THE SAME HANDLE AND ADAPTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17110846 ↗
• MalfunctionMay 18, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, PRIOR TO USE TO THE PATIENT, THE MULTI-USE LOADING UNIT DID NOT LOAD PROPERLY WITH THE ADAPTER. ANOTHER UNIT OF THE CARTRIDGE WAS USED AND IT LOADED AS NORMAL. WHEN ATTEMPTED TO RELOAD THE LOADING UNIT FOR A THIRD TIME, THE TECH BROKE OFF A SMALL PORTION OF THE END OF THE PLASTIC CARTRIDGE/RELOAD. THE RELOAD WAS NOT USED. THE SURGEON OPENED ANOTHER RELOAD AND USED IT WITH THE SAME HANDLE, SHELL AND ADAPTER TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16953620 ↗
• InjuryJul 1, 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 SLEEVE GASTRECTOMY, DURING STOMACH TRANSECTION, THE DEVICE FIRED BUT THE ENTIRE STAPLE LINE OF FIVE RELOADS WERE BLEEDING. THERE WAS POOR STAPLE FORMATION. THE ENTIRE STAPLE LINE WAS CLIPPED TO STOP THE BLEEDING.

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

  MAUDE report 14887864 ↗
• MalfunctionJul 1, 2022Misfire; Insufficient Device Problem Information; Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC SLEEVE GASTRECTOMY WHILE TRANSECTING TO THE STOMACH, THE DEVICE DID NOT FIRE. THE SURGEON ATTEMPTED TO FIRE BUT THE CARTRIDGE WOULD NOT FIRE. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE CARTRIDGE WITH NEW ONE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DEVICE WAS FOUND TO BE PARTIALLY FIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14886050 ↗
• InjuryJun 27, 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 SLEEVE GASTRECTOMY, DURING STOMACH TRANSECTION, THE DEVICE FIRED BUT THE ENTIRE STAPLE LINE OF 5 RELOADS WERE BLEEDING. THERE WAS POOR STAPLE FORMATION. THE ENTIRE STAPLE LINE WAS CLIPPED TO STOP THE BLEEDING.

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

  MAUDE report 14837843 ↗
• InjuryJun 27, 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 SLEEVE GASTRECTOMY, DURING STOMACH TRANSECTION, THE DEVICE FIRED BUT THE ENTIRE STAPLE LINE OF 5 RELOADS WERE BLEEDING. THERE WAS POOR STAPLE FORMATION. THE ENTIRE STAPLE LINE WAS CLIPPED TO STOP THE BLEEDING.

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

  MAUDE report 14837733 ↗
• InjuryJun 27, 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 SLEEVE GASTRECTOMY, DURING STOMACH TRANSECTION, THE DEVICE FIRED BUT THE ENTIRE STAPLE LINE OF 5 RELOADS WERE BLEEDING. THERE WAS POOR STAPLE FORMATION. THE ENTIRE STAPLE LINE WAS CLIPPED TO STOP THE BLEEDING.

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

  MAUDE report 14837680 ↗
• InjuryJun 27, 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 SLEEVE GASTRECTOMY, DURING STOMACH TRANSECTION, THE DEVICE FIRED BUT THE ENTIRE STAPLE LINE OF 5 RELOADS WERE BLEEDING. THERE WAS POOR STAPLE FORMATION. THE ENTIRE STAPLE LINE WAS CLIPPED TO STOP THE BLEEDING.

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

  MAUDE report 14837567 ↗
• MalfunctionMar 18, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE SLEEVE GASTRECTOMY VIA LAPAROSCOPIC PROCEDURE, WHILE TRANSECTING THE STOMACH, THE CARTRIDGE DID NOT FIRE STAPLES IN THE LOADING UNIT. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE CARTRIDGE WITH NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13815093 ↗
• MalfunctionFeb 25, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER DURING SLEEVE GASTRECTOMY VIA LAPAROSCOPIC PROCEDURE, WHILE TRANSECTING TO THE STOMACH, THE DEVICE DID NOT FIRE. THE SURGEON ATTEMPTED TO FIRE BUT THE CARTRIDGE WOULD NOT FIRE. TO RESOLVE THE ISSUE, THE SURGEON REPLACED THE CARTRIDGE WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599981 ↗
• MalfunctionJan 14, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING  STOMACH TRANSECTION IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE STAPLES WERE FIRED LESS THAN HALFWAY THROUGH THE LOAD WHEN IT RETRACTED.  THIS RESULTS TO A DISTALLY INCOMPLETE STAPLE LINE. TO RESOLVE THE ISSUE, A NEW CARTRIDGE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13261580 ↗
• MalfunctionDec 1, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROUX EN Y, WHILE PERFORMING A SMALL BOWEL ANASTOMOSIS, THE DEVICE ENTERED FIRING MODE BUT DID NOT FIRE ON FIVE CARTRIDGE'S. ON THE LAST SIXTY MILLIMETER LOADING UNIT, THE SURGEON WAS NOT ABLE TO SQUEEZED THE HANDLE AFTER PRESSING THE GREEN BUTTON. TO RESOLVE THE ISSUE, THE SURGEON USED A COMPETITOR'S DEVICE. THE SURGERY GOT EXTENDED FOR THIRTY MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12913793 ↗
• InjurySep 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, HOURS AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY, THE PATIENT HAD TO BE TAKEN BACK TO SURGERY FOR AN ADDITIONAL HOUR PROCEDURE TO CONTROL BLEEDING STAPLE LINES. SURGEON HAD TO OVER SEW THE STAPLE LINES AND A BLOOD TRANSFUSION WAS REQUIRED FOR THE BLOOD LOSS OF MORE THAN 500CC. THE PATIENT'S HOSPITAL STAY WAS ALSO EXTENDED FOR THREE DAYS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12458894 ↗
• MalfunctionApr 22, 2021Misfire; Insufficient Device Problem Information; Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY, WHEN THE JAWS WERE CLAMPED DOWN ON TISSUE, THERE WAS AN AUDIBLE "BEEP BEEP" AND THE STAPLER WOULD NOT GO INTO FIRE MODE. THE SURGICAL TECHNICIAN TOOK THE CARTRIDGE OUT, REMOVED THE LOADING UNIT AND THE ADAPTER. THEN THE SAME LOADING UNIT, SHELL AND ADAPTER WERE USED WITH THE NEW CARTRIDGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11712137 ↗
• MalfunctionMar 18, 2021Failure to Form Staple; Component or Accessory Incompatibility; Human-Device Interface Problem; Failure to Form Staple; Component or Accessory Incompatibility; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN APPLIED ON GREATER CURVATURE, UPON COMPLETION OF THE SECOND FIRING, ABOUT 5-6 STAPLES WERE NOT FORMED TOWARDS THE DISTAL END OF THE CARTRIDGE. IT WAS ALSO REPORTED THAT THERE WAS DIFFICULTY IN LOADING AND UNLOADING THE CARTRIDGE INTO THE LOADING UNIT. A THIRD FIRING WAS POSITION TO FIX THE STAPLE LINE USING THE SAME HANDLE, SHELL, ADAPTER AND LOADING UNIT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11521205 ↗
• InjuryDec 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE A GASTRIC BYPASS PROCEDURE, THERE WAS STAPLE LINE BLEEDING. PATIENT LOST A TOTAL OF 1,750 CC OF BLOOD THAT REQUIRED BLOOD TRANSFUSION. DUE TO THE POST-OPERATIVE EVENT, THE PATIENT HAD EXTENDED HOSPITALIZATION OF 3 DAYS.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 9530199 ↗
• MalfunctionDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A GASTRIC BYPASS PROCEDURE, STAPLE LINES LOOKED FINE. BLEEDING OCCURRED HOURS FOLLOWING SURGERY AFTER POST OPERATIVE ANTICOAGULANT. PATIENT HAD 250CC BLOOD LOSS BUT HAD NO ADDED LENGTH OF STAY. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9519644 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE PATIENT WAS READMITTED TO THE HOSPITAL DUE TO GASTRO INTESTINAL BLEEDING. THERE WAS BLOOD LOSS OF MORE THAN 500 CC AND THE HOSPITAL STAY WAS EXTENDED BY 2 DAYS. IT WAS NOTED THAT THE BLEEDING WAS RESOLVED SPONTANEOUSLY AFTER READMISSION.

  Patient problems: Blood Loss; No Code Available

  MAUDE report 8532572 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE A LAPAROSCOPIC GASTRIC BYPASS, THE PATIENT PRESENTED WITH A GASTROINTESTINAL BLEEDING.

  Patient problems: No Code Available

  MAUDE report 8529555 ↗
• InjuryApr 11, 2019Loss of or Failure to Bond; Failure to Form Staple; Loss of or Failure to Bond; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AT THE END OF THE JEJUNOJEJUNOSTOMY, BUBBLES WERE SAW IN THE DISTAL PART AND HAD OPENED UP. STAPLES HAVE FORMED BUT FELL AWAY FROM TISSUE AND THE SURGEON OVER SEWN LAYERS OF TISSUE WHERE THE JEJUNOSTOMY HAD OPENED UP.

  Patient problems: No Code Available

  MAUDE report 8503658 ↗

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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• 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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• 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