Tri-Staple 2.0 SIGTRS60AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 309 adverse event reports that list this exact device (DI 10884521543638), received between Feb 12, 2018 and Sep 25, 2024 — classified as 1 death, 59 injuries, 249 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (100 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 309 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2024Entrapment of Device; Retraction Problem; Entrapment of Device; Retraction Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTAL GASTRECTOMY, DURING DUODENAL RESECTION, IT WAS DIFFICULT OR IMPOSSIBLE TO RETRACT THE KNIFE BLADE, AND THE RELOAD COULD NOT REMOVE THE JAWS FROM THE TISSUE. TO RESOLVE THE ISSUE, THE JAWS WERE OPENED USING ALSO THE MANUAL ADAPTER TOOL, AND THE JAWS WERE REMOVED FROM THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305987 ↗
• MalfunctionJul 10, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING RESECTION OF THE STOMACH, THERE WAS PARTIAL FIRING AND THE KNIFE BLADE WAS RETRACTED. IT WAS NOTED THAT THE FIRING ADVANCED TO 2/3 (TWO-THIRDS) OF THE STAPLE LINE, BUT THE FIRING STOPPED, AND THE FIRING WAS UNABLE TO BE PERFORMED FOR THE REST 1/3 (ONE THIRD) OF THE LINE. THE PRODUCT WAS REPLACED BY TAKING OUT FROM ANOTHER COMPANY'S PRODUCT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713076 ↗
• MalfunctionDec 18, 2023Break; Entrapment of Device; Misfire; Break; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RECTAL RESECTION PROCEDURE, WHEN RESECTING THE RECTUM, FIRING STARTED WHILE APPLYING TENSION TO THE CARTRIDGE TO ADJUST THE ANGLE. THE PROXIMAL SITE ON THE CARTRIDGE SIDE WAS DAMAGED, THE CONNECTING PART BETWEEN THE ADAPTER AND THE CARTRIDGE BROKE WHEN THE FIRING ADVANCED ABOUT 1/3 OF THE WAY. AS THE RELOAD DID NOT DETACH (THE JAWS DID NOT OPEN), JAWS WERE FIXATED TO TISSUE, ADDITIONAL RESECTION OF THE ANAL SIDE WAS PERFORMED USING PRODUCT FROM ANOTHER COMPANY. THE SPECIMEN WAS TAKEN OUT OF THE BODY WITH THE CARTRIDGE ATTACHED. THE INCISION RANGE EXPANDED DUE TO PROBLEMS WITH THIS PRODUCT THAT DID NOT EXCEED 1 INCH (2.54 CM).

  Patient problems: Tissue Breakdown

  MAUDE report 18350980 ↗
• MalfunctionNov 30, 2023Entrapment of Device; Misfire; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER, DURING AN OPEN LAPAROTOMY GASTRIC SLEEVE, DURING STAPLING, THE STAPLE WAS STUCK IN THE MIDDLE OF THE STAPLE LINE AND THE JAWS LOCK ON TISSUE. THE JAWS WERE PARTIALLY REMOVED AND WAS REINFORCED WITH OTHER STAPLING BY USING A BLACK RELOAD WITH THE SAME POWERED STAPLER.

  Patient problems: Tissue Breakdown

  MAUDE report 18243569 ↗
• MalfunctionJul 18, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A SLEEVE GASTRECTOMY PROCEDURE, WHILE AT FOURTH FIRING, THE RELOAD LOADED AND CYCLED PROPERLY, HOWEVER DURING FIRING, THE RELOAD DID NOT FIRE ALL THE WAY TO THE END OF THE RELOAD. THERE WERE NO ISSUES WITH OPENING THE RELOAD, BUT SCRUB NURSE COULD NOT GET RELOAD OFF ADAPTER BETWEEN FIRINGS. ATTEMPTED MANUAL RETRACTION TOOL, WHICH DID NOT WORK. THE ADAPTER WAS REPLACED TO FINISH CASE AND HAD NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY. IT WAS NOTED THAT CLINICAL SPECIALIST WAS ABLE TO GET RELOAD OPEN AND OFF ADAPTER WITH MANUAL RETRACTION TOOL WITHOUT ISSUES, HOWEVER ACKNOWLEDGED DIFFICULTY WITH TWISTING PROCESS TO REMOVE RELOAD FROM ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347605 ↗
• MalfunctionJul 6, 2023Entrapment of Device; Misfire; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC THORACOSCOPIC PARTIAL PULMONARY RESECTION, SEVERAL STAPLES ON THE TIP WERE NOT FIRED WHEN THE PULMONARY PARENCHYMA WAS RESECTED, AND REMAINED IN THE CARTRIDGE WITH THE U SHAPE. THERE WAS AN INCOMPLETE STAPLE LINE DISTALLY. IT WAS RECOGNIZE THAT FIRMLY SQUEEZED IT TILL THE TIP, BUT THE ANCHORING SUTURE ALSO DID NOT CAME OFF, SO FORCEPS WAS USED TO DETACHED THE SHEET FROM THE CARTRIDGE. THE JAWS WERE ALSO LOCKED ON TISSUE AND WAS REMOVED AS USUAL. A NEW CARTRIDGE WAS USED TO RESECT THE PART THAT WAS NOT RESECTED. IT WAS NOTED THAT THE SAME HANDLE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266028 ↗
• MalfunctionJul 3, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC TAIL RESECTION, WHILE USING THE 60MM PURPLE RELOAD, THE RELOAD FIRED A L ITTLE, THEN THE DEVICE NO LONGER ADVANCED. THE JAWS OF THE DEVICE WERE FIXATED IN THE TISSUE BUT WAS EVENTUALLY REMOVED. WHEN A NEW 60MM PURPLE RELOAD WAS USED TOGETHER WITH THE SAME HANDLE, SHELL AND ADAPTER, THE PROCEDURE CONTINUED WITHOUT ANY PROBLEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17246492 ↗
• MalfunctionJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING RESECTION OF THE STOMACH, THERE WAS A BLEEDING ALONG WHOLE THE STAPLE LINE OF THE FOUR RELOADS. THE SURGEON OVER SEWN THE TISSUE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17158168 ↗
• MalfunctionJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING RESECTION OF THE STOMACH, THERE WAS A BLEEDING ALONG WHOLE THE STAPLE LINE OF THE FOUR RELOADS. THE SURGEON OVER SEWN THE TISSUE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17157822 ↗
• MalfunctionJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING RESECTION OF THE STOMACH, THERE WAS A BLEEDING ALONG WHOLE THE STAPLE LINE OF THE FOUR RELOADS. THE SURGEON OVER SEWN THE TISSUE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17157631 ↗
• MalfunctionJun 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING RESECTION OF THE STOMACH, THERE WAS A BLEEDING ALONG WHOLE THE STAPLE LINE OF THE FOUR RELOADS. THE SURGEON OVER SEWN THE TISSUE TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17124633 ↗
• MalfunctionMar 23, 2023Misfire; Insufficient Device Problem Information; Misfire; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE DEVICE PARTIALLY FIRED DISTALLY AND WOULD NOT FIRE ALL THE WAY. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16601282 ↗
• MalfunctionMar 3, 2023Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, RESECTION WAS PERFORMED IN SLOW MODE ON THE DUODENAL REGION USING THE POWERED HANDLE WITH REINFORCEMENT RELOAD DURING A ROBOT-ASSISTED PYLORIC GASTRECTOMY (ZONE 2). THE SCREEN DISPLAYED NORMALLY DURING CLAMPING AND FIRING, BUT AFTER FIRING UNTIL THE END, AN ABNORMAL SCREEN WAS DISPLAYED AND IT NO LONGER ACCEPTED OPERATION. AFTER ARTICULATION, WHILE THE KNIFE DID NOT RETURN, THE JAWS WERE ANCHORED. THE HANDLE WAS REMOVED FROM THE ADAPTER AND WAS RECONNECTED, BUT THE SCREEN REMAINED THE SAME AND DID NOT IMPROVE. AFTER USING THE MANUAL ADAPTER TOOL, THE KNIFE RETURNED AND JAWS WERE RELEASED FROM THE TISSUE. THE POWER HANDLE CONTINUED TO SOUND A WARNING SOUND WHILE DISPLAYING THE ABNORMAL SCREEN. SURGICAL TIMES WERE EXTENDED BY 20 TO 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16481999 ↗
• MalfunctionFeb 24, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOT-ASSISTED ESOPHAGEAL RESECTION PROCEDURE, AT THE TIME OF TISSUE RESECTION, AFTER CONNECTING THE RELOAD INTO THE HANDLE AND PRESSING THE GREEN BUTTON, THE SURGEON COULD NOT SQUEEZE THE HANDLE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16435056 ↗
• MalfunctionFeb 23, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPY PARTIAL RIGHT PULMONARY RESECTION PROCEDURE, AT THE TIME OF RESECTIONING THE LOWER LOBE OF THE RIGHT LUNG, AFTER THE TISSUE WAS APPROACHED AND THE JAWS OF THE THE 45 REINFORCED RELOAD WAS CLOSED TO PERFORM FIRING, THE GREEN BUTTON DID NOT LIGHT UP. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. A 60 REINFORCED RELOAD WAS THEN SET ON THE TISSUE AND FIRED, BUT THE RELOAD STOPPED FIRING MIDWAY. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429886 ↗
• MalfunctionFeb 10, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, THE FIRING STOPPED MIDWAY AND WAS RELEASED AS USUAL. TO RESOLVE THE ISSUE, A NEW HANDLE AND RELOAD WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353806 ↗
• MalfunctionFeb 2, 2023Retraction Problem; Misfire; Retraction Problem; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PARTIAL PULMONARY RESECTION, IN PARENCHYMA RESECTION, WHEN FIRING WAS ATTEMPTED, FIRING COULD NOT ADVANCE. THE DEVICE WAS ALSO DIFFICULT TO RELEASE. EVENTUALLY, THE BLACK RETURN KNOB RETURNED AND THE DEVICE WAS RELEASED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16285054 ↗
• MalfunctionOct 29, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS, THE RELOAD HAD ONLY FIRED HALFWAY AND THAT THE REMAINING BUTTRESS MATERIAL HAD DETACHED FROM THE RELOAD AND WAS HANGING OFF THE END OF THE STAPLE LINE. THE EXCESS BUTTRESS MATERIAL WAS THEN CUT AWAY AND REMOVED. IT WAS ALSO STATED THAT THERE WAS NO ERROR ON THE POWERED HANDLE. ANOTHER RELOAD WAS REQUESTED AND USED BY THE SURGEON TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15696395 ↗
• MalfunctionOct 28, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PANCREATIC TAIL RESECTION,  WHEN THE TISSUE WAS GRASPED, THE SURGEON PRESSED THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZED THE HANDLE. THE RETURN KNOB COULD NOT BE RETURNED. WHEN THE HANDLE WAS GRIPPED TIGHTLY AGAIN, THERE WAS A CRACKING SOUND HEARD AND THE RETURN KNOB WAS ABLE TO RETURN TO ITS PLACE. THE DEVICE DID NOT FIRE. A NEW HANDLE AND CARTRIDGE WERE USED IN ORDER TO COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 15691131 ↗
• InjuryOct 5, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION, WHEN THE ANAL RECTUM WAS SEPARATED, AFTER GRIPPING THE TISSUE, THE GREEN BUTTON WAS PRESSED AND THE STAPLER WAS STARTED, BUT THE STAPLER STOPPED MIDWAY. THE BUTTON WAS PRESSED AGAIN BUT IT DID NOT MOVE, SO AFTER THE RELEASE BUTTON WAS PRESSED AND THE JAW WAS OPENED, THE REINFORCE SHEET WAS REMOVED. THE RECTUM CLOSER TO THE ANUS WAS FURTHER CUT OFF USING OTHER COMPANY'S DEVICE AND ANASTOMOSIS WAS PERFORMED. WITHOUT FIXATING, A NEW PRODUCT FROM ANOTHER COMPANY WAS USED TO PERFORM THE INCISION AND SUTURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15544802 ↗
• InjurySep 29, 2022Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC COLON ANASTOMOSIS PROCEDURE, THERE WAS POOR STAPLE FORMATION AND THE STAPLE LINE WAS IN COMPLETE DISTALLY. THERE WAS TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THE MUCOUS MEMBRANE TORE. IT WAS DEALT WITH ADDITIONAL SUTURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15502670 ↗
• MalfunctionSep 7, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING AN OPEN ABDOMINAL LAPAROTOMY DISTAL PANCREATECTOMY, WHEN RESECTING THE PANCREAS, THE FIRING STOPPED IN THE MIDDLE AND IMMEDIATELY RETURNED AFTER FIRING WAS PERFORMED. THE JAWS OF THE DEVICE LOCKED ON TISSUE BUT WAS ABLE TO BE REMOVED BY OPENING THE JAWS; THE DEVICE WAS REMOVED. ANOTHER POWERED HANDLE AND ADAPTER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15372251 ↗
• MalfunctionAug 26, 2022Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RESPIRATORY SURGERY, WHEN THE JAWS WERE OPENED AFTER THE FIRING WAS PERFORMED ON THE TISSUE, THE CARTRIDGE WAS UNABLE TO BE REMOVED PROPERLY FROM THE TISSUE. CUT OFF THE REINFORCEMENT WITH SCISSORS AND REMOVED IT. USED ANOTHER REINFORCEMENT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306059 ↗
• MalfunctionAug 23, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE STAPLER WAS UNABLE TO FIRE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND COULD SQUEEZE THE HANDLE. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15278938 ↗
• MalfunctionJul 29, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING DISTAL PANCREATECTOMY, WHILE CONNECTING THE RELOAD INTO THE HANDLE, THE BLACK RESIN AT THE PROXIMAL END OF THE RELOAD SIDE BROKE AND IT COULD NOT BE CONNECTED TO THE HANDLE PROPERLY. ANOTHER RELOAD WAS USED TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136270 ↗

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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• 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-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• 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-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-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• 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