Tri-Staple 2.0 SIG30AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 10884521543652), received between Aug 4, 2017 and Aug 12, 2026 — classified as 10 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (31 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 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50222221 ↗
• MalfunctionJun 30, 2026Entrapment of Device; Retraction Problem; Difficult to Open or Close; Human-Device Interface Problem

  IT WAS REPORTED THAT, DURING A ROBOTIC RADICAL PROSTATECTOMY USING THE POWERED STAPLING SYSTEM WITH AN XL ADAPTER AND A RELOAD, THE KNIFE BLADE WAS DIFFICULT TO RETRACT AFTER FIRING WHILE DIVIDING THE DORSAL VEIN, AND THE JAWS WOULD NOT OPEN WHILE STILL ON THE TISSUE. THE DEVICE WAS REPORTED TO BE LOCKED ON THE TISSUE AND DIFFICULT TO REMOVE FROM THE PATIENT. THE STAPLE RELOAD COULD NOT BE OPENED, REMOVED FROM THE ADAPTER, OR UNLOADED. IT WAS REPORTED THAT THE STAPLE RELOAD JAWS WERE PULLED OFF THE TISSUE, RESULTING IN TEARING AND TISSUE/SKIN DAMAGE OR TRAUMA TO THE DORSAL VEIN. THE PROCEDURE WAS REPORTED TO HAVE BEEN PROLONGED BY APPROXIMATELY 30 MINUTES, AND THE PATIENT WAS REPORTED TO BE ALIVE WITH INJURY. TROUBLESHOOTING STEPS WERE PERFORMED, INCLUDING LIFTING UP ON THE TOGGLE, REMOVING AND REATTACHING THE ADAPTER, AND RESETTING THE POWER HANDLE. A MANUAL RETRACTION TOOL WAS USED IN THE CENTER PORT OF THE ADAPTER AND TURNED CLOCKWISE. RESISTANCE WAS FELT ON THE FIRST TURN, AFTER WHICH NO RESISTANCE WAS FELT. IT WAS REPORTED THAT THE TOOL DID NOT RETRACT THE KNIFE BLADE, AND THE TOP OF THE I-BEAM WAS NOT VISIBLE FOR TRACKING PROGRESS. THE DEVICE WAS REPLACED, AND THE TEAM TRANSI

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 25663687 ↗
• MalfunctionJun 4, 2026Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS PROCEDURE, AN INCOMPLETE STAPLE LINE OCCURRED, WITH APPROXIMATELY 5MM OF MISSING STAPLES AT THE DISTAL PORTION OF THE ANASTOMOSIS, RESULTING IN A LEAK AT THE RECONSTRUCTED STOMACH POUCH. TO RESOLVE THE ISSUE, THE SURGEON PERFORMED A MANUAL SUTURE TO SECURE THE ANASTOMOSIS. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 15 MINUTES DUE TO THE ISSUE.

  Patient problems: Failure to Anastomose

  MAUDE report 25403088 ↗
• MalfunctionMay 7, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRING OF THE STAPLER COULD NOT BE DONE AT ALL. ANOTHER RELOAD AND HANDLE WERE USED TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 21977037 ↗
• MalfunctionNov 27, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, SIGMOID COLON RESECTION, THE FIRING COULD NOT BE PERFORMED AT ALL. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20802739 ↗
• MalfunctionOct 7, 2024Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY RESECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, AND WHEN THE HANDLE WAS SQUEEZED, IT WAS HARD, AND THE DEVICE BECAME UNABLE TO FIRE IN THE MIDDLE, AND IT WAS NOT COMPLETED. THE HANDLE AND RELOAD WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20386541 ↗
• MalfunctionJul 19, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PARTIAL LUNG RESECTION, FIRING COULD NOT BE DONE AT ALL. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19785216 ↗
• MalfunctionJul 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY, THE SURGEON COULD NOT SQUEEZE THE HANDLE. THE FIRING COULD NOT BE DONE AT ALL. TO RESOLVE THE ISSUE, ANOTHER RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735885 ↗
• MalfunctionMay 6, 2024Failure to Form Staple; Failure to Cut; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LOBECTOMY, WHEN ON THE DIVISION OF THE BRONCHUS, THE STAPLES DID NOT FORMED/CRIMPED FULLY. IT WAS ALSO NOTED THAT AFTER FIRING THE RELOAD, IT DID NOT TRANSECT THE TISSUE AND LEFT WITH SIX ROWS OF STAPLES. ANOTHER MANUFACTURER STAPLER WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE.

  Patient problems: Tissue Breakdown

  MAUDE report 19250538 ↗
• MalfunctionApr 10, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE DEVICE DID NOT FIRE.

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

  MAUDE report 19080815 ↗
• MalfunctionMar 12, 2024Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A COLORECTAL SURGERY, OPENING AND CLOSING THE JAWS WERE TROUBLESOME AND IT WAS NOT POSSIBLE TO MOVE THE STAPLE RELEASE SYSTEM FORWARD. THE RELOAD DID NOT FIRE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 18886769 ↗
• MalfunctionFeb 1, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING THE VIDEO ASSISTED THORACOSCOPY SURGERY WEDGECTOMY, WHILE ATTEMPTING TO STAPLE AROUND TUMOR LUNG TISSUE, THE 30 MILLIMETER PURPLE RELOAD FIRED CORRECTLY. THE SECOND FIRING WITH POWER HANDLE WAS 45 MILLIMETER BLACK RELOAD, DURING THIS FIRING, THE FIRING WAS ABLE TO BE COMPLETED BUT THE SURGEON DESCRIBE THE RELOAD AS PUSHING BACK ON THE TISSUE OR NOT FULLY STAPLING AND CUTTING THE TISSUE AS FAR AS EXPECTED BASED ON INITIAL POSITIONING OF THE RELOAD. ON THE THIRD 45 MILLIMETER RELOAD FIRING, THE ISSUE OCCURRED AGAIN WITH FULL FIRING OF THE RELOAD BUT NO ADVANCEMENT OF THE TISSUE TRANSECTION OCCURRED. THERE WERE MORE STAPLES BUILT UP ON THE TISSUE WITH LITTLE TO NO ADVANCEMENT OF THE STAPLE CUT LINE. DURING THE FOURTH FIRING OF ANOTHER 45 MILLIMETER BLACK RELOAD, THE POWER HANDLE SCREEN SHOWED THE EXCESSIVE THICKNESS AFTER FIRING TO THE CENTRAL PORTION OF THE STAPLE LINE. THE SURGEON WAITED TO ALLOW THE TISSUE MORE TIME TO COMPRESS AND FIRED FURTHER ANOTHER 1-2 MM AND THE EXCESSIVE ICON STOPPED THE STAPLER AGAIN. THE POWER HANDLE WAS UNABLE TO ADVANCE ANY FURTHER SO THE STAPLER WAS REMOVED. DURING THE FIFTH FIRING OF ANOTHER 45MILLIMETER BLACK RELOAD,

  Patient problems: Insufficient Information

  MAUDE report 18624585 ↗
• MalfunctionSep 13, 2023Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, IN A ROBOTIC LAPAROSCOPIC PROSTATECTOMY, THE DISTAL STAPLE DID NOT FORM. THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE SURGEON PERFORMED CAUTERY TO FIX THE STAPLE LINE.

  Patient problems: Tissue Breakdown

  MAUDE report 17736956 ↗
• MalfunctionAug 17, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC CHOLECYSTECTOMY, BEFORE BILE DUCT RESECTION, WHEN THE TISSUE WAS CLAMPED, THE GREEN BUTTON WAS PRESSED, AND AN ATTEMPT WAS MADE TO PERFORM FIRING, BUT FIRING COULD NOT BE PERFORMED. THE HANDLE COULD NOT BE SQUEEZED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17565995 ↗
• MalfunctionJun 7, 2023Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC LOW ANTERIOR RESECTION, THE RELOAD WAS CONNECTED TO THE HANDLE AND TRIED TO OPEN AND CLOSE THE JAWS BEFORE HANDING IT OVER TO THE DOCTOR, HOWEVER, THE OPENING AND CLOSING COULD NOT BE DONE PROPERLY. A NEW RELOAD WAS TAKEN TO COMPLETE THE CASE. THE HANDLE WAS ABLE TO FIRE AFTER REPLACING THE RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17081064 ↗
• MalfunctionMay 23, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC PROSTATE PROCEDURE, IN FIRING ON THE DORSAL VENOUS COMPLEX (DVC), THE DEVICE FIRED ONLY ABOUT EIGHTEEN MILLIMETER. THE HANDLE MADE A LOUD POPPING NOISE. TO RESOLVE THE ISSUE, SUTURE AND ENERGY DEVICE WAS USED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16984172 ↗
• MalfunctionApr 26, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, AFTER PRESSING THE GREEN BUTTON, THE PURPLE RELOAD WAS BEING FIRED ACROSS THE STOMACH. THE POWER HANDLE SHOWED A TISSUE TOO THICK ALERT AND COULD NOT COMPLETE THE FIRING HALFWAY THROUGH. THE SURGEON DECIDED TO USE A BLACK RELOAD ON THE NEXT FIRING, WHICH ALSO HAD A THICK TISSUE ALERT AND IT STOPPED THE FIRING HALFWAY. IT WAS MOST LIKELY CAUSED BY THE STAPLES THAT BUILD UP FROM THE PURPLE RELOAD IN THE CROTCH. THE SURGEON PAUSED AND WAS ABLE TO COMPLETE THE FIRING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815201 ↗
• MalfunctionApr 18, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC APPENDECTOMY, WHEN STAPLING THE APPENDIX, A PIECE OF THE YELLOW SHIPPING WEDGE BROKE OFF AND FELL INTO THE PATIENT. THE SURGEON WAS ABLE TO RECOVER IT LAPAROSCOPICALLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16764727 ↗
• MalfunctionNov 2, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING AN APPENDICECTOMY, STAPLES WERE MISSING IN THE CARTRIDGE AND MECHANISM WAS NOT FUNCTIONAL. THE DEVICE DID NOT COMPLETELY CLOSE THE STRUCTURE.

  Patient problems: Insufficient Information

  MAUDE report 15714915 ↗
• MalfunctionSep 27, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE DID NOT FIRE. 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 15495483 ↗
• InjurySep 17, 2022Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A TRANSHIATAL ESOPHAGECTOMY, THE STAPLER WAS ATTEMPTED TO BE USE IN THE NECK AT AN ANASTOMOSIS SITE. IT WAS CLAMPED ON THE TISSUE AND THE RELEASE BUTTON WAS ACTIVATED AND THEN FIRED AS PER NORMAL. WHEN THE STAPLER WAS REMOVED IT WAS NOTED THAT NO STAPLES HAD BEEN FIRED. THE PATIENT WAS POTENTIAL FOR BLEEDING AND EXTENDED THE PROCEDURAL TIME. THE SURGEON USED A NEW RELOAD TO RESOLVE THE ISSUE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15443094 ↗
• MalfunctionSep 2, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY, RELOAD WAS LOADED INTO THE STAPLER, WHEN THE SURGEON ATTEMPTED TO FIRE THE STAPLER, NOTHING HAPPENED. UPON FURTHER INSPECTION, THE STAPLER HAD MISFIRED. THE STAPLE LOAD WAS THEN IMMEDIATELY REMOVED FROM THE STERILE FIELD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15351481 ↗
• MalfunctionAug 23, 2022Failure to Fire; Protective Measures Problem; Failure to Fire; Protective Measures Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC SIGMOIDECTOMY, ON THE DIVISION OF THE DISTAL SIGMOID, THE SURGEON HAD STAPLED ACROSS THE DISTAL END OF THE SIGMOID COLON TO DIVIDE AND THE FIRST FIRE WENT FINE. A SMALL AMOUNT OF TISSUE WAS LEFT AND THE 30 MILLIMETER PURPLE RELOAD WAS OPENED. THE TISSUE WAS PLACED IN THE JAWS OF THE RELOAD. THE SURGEON LIFTED THE STAPLER TO REPOSITION WHILE THE TISSUE WAS IN THE JAWS AND THE TISSUE WAS SLICED THE REST OF THE WAY. THE DEVICE WAS NOT FIRED OR CLOSED, BUT IT CUT THE TISSUE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. 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 15275880 ↗
• MalfunctionAug 18, 2022Misfire

  TRI-STAPLE 2.0 RELOAD WAS LOADED INTO THE STAPLER BY THE TECH. WHEN THE SURGEON ATTEMPTED TO FIRE THE STAPLER, NOTHING HAPPENED. UPON FURTHER INSPECTION, THE TECH COULD SEE THAT THE STAPLER HAD MISFIRED. THE PATIENT UNHARMED. THE STAPLE LOAD WAS THEN IMMEDIATELY REMOVED FROM THE STERILE FIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15248514 ↗
• MalfunctionApr 27, 2022Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC APPENDECTOMY, AT APPENDIX RESECTION, AFTER PRESSING DOWN THE GREEN BUTTON, THE HANDLE WAS SQUEEZED BUT THE FIRING COULD NOT BE PERFORMED. THE JAWS OF THE DEVICE ALSO LOCKED ON TISSUE. THE DEVICE WAS REMOVED NORMALLY FROM THE TISSUE. A NEW HANDLE AND RELOAD WERE USED TO COMPLETE THE CASE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219695 ↗

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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• 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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• 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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• 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-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