Tri-Staple 2.0 SIGC60MTRecalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 10884521543584), received between Sep 25, 2017 and Sep 21, 2026 — classified as 28 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (36 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 81 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Entrapment of Device; Retraction Problem

  Patient problems: Tissue Breakdown

  MAUDE report 50847071 ↗
• MalfunctionApr 6, 2026Misfire; Failure to Form Staple

  IT WAS REPORTED THAT, DURING A LOW ANTERIOR RESECTION (LAR), WHILE BEING APPLIED ON THE SIGMOID COLON, THE DEVICE GOT STUCK, RESULTING IN ONLY PARTIAL STAPLE FORMATION. SOME STAPLES FORMED IN A PROPER ¿B¿ SHAPE, WHILE THE REMAINING STAPLES WERE MALFORMED. THE PROCEDURE WAS EXTENDED BY 1 HOUR. THE DEVICE WAS REPLACED WITH ANOTHER RELOAD, AND SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

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

  MAUDE report 24795264 ↗
• MalfunctionFeb 2, 2026Misfire; Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE LOADING UNITS AND RELOADS WITH A POWERED STAPLER AND XL ADAPTER, THE RELOADS WERE NOT ABLE TO FORM PROPER B STAPLES, STAPLES THAT OPENED AND COULD NOT CLOSE FULLY, STAPLES FELL INTO THE ABDOMINAL CAVITY, RELOADS WERE NOT ABLE TO FIRE FULLY, INCOMPLETE STAPLE LINES, AND THE DEVICE NOT BEING ABLE TO FIRE EVEN WITH NEW BLADES AND RELOADS WHICH RESULTED TO EXTENDED SURGICAL TIME OF TWO HOURS DUE TO MULTIPLE DEVICE ISSUES. IT WAS CONFIRMED THAT THE STAPLES WERE RETRIEVED BY HAND INSTRUMENTS. TROUBLESHOOTING INVOLVED REPLACING THE DEVICE WITH NEW BLADES AND RELOADS, BUT THE SAME ISSUES PERSISTED, LEADING TO THE USE OF STAPLERS FROM ANOTHER COMPANY.

  Patient problems: Tissue Breakdown

  MAUDE report 24242765 ↗
• MalfunctionFeb 2, 2026Misfire; Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE LOADING UNITS AND RELOADS WITH A POWERED STAPLER AND XL ADAPTER, THE RELOADS WERE NOT ABLE TO FORM PROPER B STAPLES, STAPLES THAT OPENED AND COULD NOT CLOSE FULLY, STAPLES FELL INTO THE ABDOMINAL CAVITY, RELOADS WERE NOT ABLE TO FIRE FULLY, INCOMPLETE STAPLE LINES, AND THE DEVICE NOT BEING ABLE TO FIRE EVEN WITH NEW BLADES AND RELOADS WHICH RESULTED TO EXTENDED SURGICAL TIME OF TWO HOURS DUE TO MULTIPLE DEVICE ISSUES. IT WAS CONFIRMED THAT THE STAPLES WERE RETRIEVED BY HAND INSTRUMENTS. TROUBLESHOOTING INVOLVED REPLACING THE DEVICE WITH NEW BLADES AND RELOADS, BUT THE SAME ISSUES PERSISTED, LEADING TO THE USE OF STAPLERS FROM ANOTHER COMPANY.

  Patient problems: Tissue Breakdown

  MAUDE report 24242732 ↗
• MalfunctionFeb 2, 2026Misfire; Failure to Form Staple; Failure to Fire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE LOADING UNITS AND RELOADS WITH A POWERED STAPLER AND XL ADAPTER, THE RELOADS WERE NOT ABLE TO FORM PROPER B STAPLES, STAPLES THAT OPENED AND COULD NOT CLOSE FULLY, STAPLES FELL INTO THE ABDOMINAL CAVITY, RELOADS WERE NOT ABLE TO FIRE FULLY, INCOMPLETE STAPLE LINES, AND THE DEVICE NOT BEING ABLE TO FIRE EVEN WITH NEW BLADES AND RELOADS WHICH RESULTED TO EXTENDED SURGICAL TIME OF TWO HOURS DUE TO MULTIPLE DEVICE ISSUES. IT WAS CONFIRMED THAT THE STAPLES WERE RETRIEVED BY HAND INSTRUMENTS. TROUBLESHOOTING INVOLVED REPLACING THE DEVICE WITH NEW BLADES AND RELOADS, BUT THE SAME ISSUES PERSISTED, LEADING TO THE USE OF STAPLERS FROM ANOTHER COMPANY.

  Patient problems: Tissue Breakdown

  MAUDE report 24242724 ↗
• MalfunctionNov 3, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING SLEEVE GASTRECTOMY, WHEN USING THE RELOAD, THE STAPLES WERE MALFORMED AND THERE WAS BLEEDING FROM THE STAPLE LINE. THE SURGEON RESECTED THE MALFORMED STAPLE LINE AND RE-STAPLED WITH A NEW CARTRIDGE.

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

  MAUDE report 23460491 ↗
• MalfunctionJul 17, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE DEVICE PARTIALLY FIRED, WHICH LED TO EXTENDED SURGICAL TIME OF MORE THAN 30 MINUTES. THE PROCEDURE REQUIRED RESECTING AND RE-STAPLING.

  Patient problems: Tissue Breakdown

  MAUDE report 22531814 ↗
• MalfunctionJun 17, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLE LINE WAS INCOMPLETE. SUTURING WAS DONE TO FIX THE STAPLE LINE.

  Patient problems: Tissue Breakdown

  MAUDE report 22235005 ↗
• MalfunctionMay 27, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC COLECTOMY, THE RELOAD COULD NOT BE FIRED. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH A NEW RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22093102 ↗
• InjuryMar 20, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE USE OF THE TRI 2.0 SIGC60MT 60 MED THK CARTRIDGE, THERE WERE FIRING ISSUES WITH THE RELOAD, IMPROPER B STAPLE FORMATION, AND AN INCOMPLETE STAPLE LINE AT THE DISTAL END. ADDITIONALLY, THERE WAS BLEEDING ALONG THE STAPLE LINE AFTER COMPLETE FIRING. THE RESOLUTION REQUIRED RESECTION AND RE-STAPLING. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Tissue Breakdown

  MAUDE report 21659975 ↗
• MalfunctionSep 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY PROCEDURE, BOTH DEVICES DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE HANDLE WAS UNABLE TO BE SQUEEZED. SUTURING WAS DONE INSTEAD TO RESOLVE THE ISSUE. THE HANDLE WAS ABLE TO FIRE OTHER RELOAD WITHOUT ISSUE.

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

  MAUDE report 20292177 ↗
• MalfunctionSep 24, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A HEMICOLECTOMY PROCEDURE, BOTH DEVICES DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT THE HANDLE WAS UNABLE TO BE SQUEEZED. SUTURING WAS DONE INSTEAD TO RESOLVE THE ISSUE. THE HANDLE WAS ABLE TO FIRE OTHER RELOAD WITHOUT ISSUE.

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

  MAUDE report 20292084 ↗
• MalfunctionSep 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SLEEVE PLUS PROCEDURE, WHEN FIRING ON THE STOMACH, IT STUCK IN BETWEEN. IT WAS NOTED THAT RELOADS STOPPED FIRING HALFWAY, AND IT OCCURRED ON THREE RELOADS. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190562 ↗
• MalfunctionSep 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SLEEVE PLUS PROCEDURE, WHEN FIRING ON THE STOMACH, IT STUCK IN BETWEEN. IT WAS NOTED THAT RELOADS STOPPED FIRING HALFWAY, AND IT OCCURRED ON THREE RELOADS. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190535 ↗
• MalfunctionSep 11, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SLEEVE PLUS PROCEDURE, WHEN FIRING ON THE STOMACH, IT STUCK IN BETWEEN. IT WAS NOTED THAT RELOADS STOPPED FIRING HALFWAY, AND IT OCCURRED ON THREE RELOADS. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190490 ↗
• MalfunctionJun 17, 2024Misfire; Detachment of Device or Device Component; Misfire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, ON THE THIRD FIRING, THE CARTRIDGE OF THE RELOAD DISLODGED FROM THE LOADING UNIT AND WAS PUSHED OUT, DEPLOYING STAPLES AND CUTTING WITHOUT FIRING. AS A RESULT, MORE TISSUE WAS NEEDED TO BE RESECTED DUE TO CUTTING WITHOUT STAPLING. THE STAPLES DID MISFIRE, HOWEVER, THE SURGEON HAD TO REMOVE UNFORMED STAPLES. TO RESOLVE THE ISSUE, THE SURGEON HAD TO REFIRE THE STAPLER USING A NEW RELOAD. THE SURGEON SUTURED OVER THE PART THAT WAS MISFIRED.

  Patient problems: Tissue Breakdown

  MAUDE report 19552746 ↗
• MalfunctionApr 10, 2024Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, AT THE TIME OF CREATING A STOMACH POUCH DURING A REVISION OF SLEEVE TO BYPASS SURGERY, THE DEVICE FIRED HALFWAY AND STOPPED, CREATED MALFORMED STAPLES IN THE MIDDLE OF THE RELOAD, AND THE FIRED STAPLE LINE WAS INCOMPLETE. THE SURGEON USED A NEW CARTRIDGE WITH THE SAME LOADING UNIT AND POWERED DEVICES TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19079579 ↗
• MalfunctionMar 20, 2024Failure to Cycle; Failure to Cycle

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL GASTRECTOMY, DURING RESECTION OF THE PARTIAL STOMACH EXTRACORPOREAL, THE FIRING SEQUENCE BEGAN, THE KNIFE BLADE ADVANCED FORWARD BUT PUSHED THE TISSUE OUT OF THE JAWS, AND IT DID NOT RESECT. THE STAPLES FORMED, BUT NOT ON THE TISSUE. A NEW RELOAD WAS ATTACHED AND THE SURGEON REPOSITIONED FROM THE OTHER SIDE OF THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18947182 ↗
• MalfunctionMar 13, 2024Failure to Fire; Component or Accessory Incompatibility; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RYGB (ROUX-EN-Y GASTRIC BYPASS) PROCEDURE, THE DEVICE MALFUNCTIONED; IT WAS DIFFICULT TO LOAD AND THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN TWO RELOADS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899659 ↗
• MalfunctionMar 13, 2024Failure to Fire; Component or Accessory Incompatibility; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RYGB (ROUX-EN-Y GASTRIC BYPASS) PROCEDURE, THE DEVICE MALFUNCTIONED; IT WAS DIFFICULT TO LOAD AND THE DEVICE DID NOT FIRE. THE ISSUE OCCURRED IN TWO RELOADS. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899648 ↗
• MalfunctionJan 22, 2024Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN AN OPEN LOWER ANTERIOR RESECTION, DURING RESECTION, THE DEVICE DID NOT FIRE. IMPROPER B SHAPED STAPLE FORMATION. THE SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 18555952 ↗
• MalfunctionJun 29, 2023Misfire; Insufficient Device Problem Information; Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC COLECTOMY, WHEN LOADING THE STAPLER, THE JAWS CLOSED BUT THE STAPLER WOULD NOT RE COGNIZED THE LOADING UNIT AND THE JAWS WOULD NOT RE-OPEN. USED ANOTHER LOADING UNIT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DEVICE PARTIALLY FIRED. STAPLES WERE PROTRUDING FROM THE PROXIMAL END OF THE STAPLE CARTRIDGE CHANNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231965 ↗
• MalfunctionJun 6, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MINI GASTRIC BYPASS, DURING STOMACH RESECTION, THE STAPLE LINE WAS INCOMPLETE PROXIMALLY AND HAD POOR STAPLE FORMATION. THE SURGEON SUTURED THE TISSUE TO RESOLVE THE ISSUE AND A NEW RELOAD WAS USED TO COMPLETE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17070210 ↗
• MalfunctionApr 21, 2023Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, IN TRANSECTING THE STOMACH TISSUE TO CREATE THE SLEEVE, AFTER THE STAPLE LINE WAS COMPLETE, THE USER RETRACTED THE KNIFE BLADE ASSEMBLY. AS THE SURGEON TRIED TO PULL THE RELOAD AWAY FROM THE STOMACH TISSUE, SOME OF THE TISSUE WAS LODGED IN THE KNIFE BLADE TRACK. THE SURGEON WAS ABLE TO REMOVE THE TISSUE WITHOUT ISSUE AFTER A FEW MINUTES OF MANIPULATION. THE STAPLE LINE WAS INSPECTED AND ALL WAS COMPLETE AND INTACT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792428 ↗
• MalfunctionApr 13, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, PRIOR TO FIRING, THE FIRST CARTRIDGE ATTACHED TO THE LOADING UNIT WOULD ONLY ARTICULATE ABOUT 15-20 DEGREES. ANOTHER LOADING UNIT AND CARTRIDGE WERE USED NEXT BUT STAPLER STOPPED FIRING HALFWAY THROUGH WHILE THERE WAS NO EXCESSIVE FORCE SIGNAL. THE HANDLE STILL SHOWED ZONES 1-3 AND IT WOULD NOT MOVE FORWARD AT ALL. SURGEON RETRACTED THE DEVICE AND USED A SINGLE-USE RELOAD TO CONTINUE THE CASE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16738219 ↗

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-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• 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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• 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