Tri-Staple 2.0 SIGTRSB60AXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 615 adverse event reports that list this exact device (DI 10884521717633), received between Nov 30, 2018 and Sep 23, 2026 — classified as 1 death, 79 injuries, 535 malfunctions.

The most frequently reported specific device problem is “Misfire” (280 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K173270); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 15, 2024Open, Classified

   Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery

   Z-1891-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 615 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Break

  According to the reporter, during a laparoscopic pancreatic resection, a yellow tab fell into the patient¿s abdominal cavity, but it was removed without changing the technique, and all parts were confirmed to have been retrieved. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863587 ↗
• MalfunctionSep 18, 2026Insufficient Device Problem Information

  According to the reporter, during a laparoscopic distal pancreatectomy, the handle/trigger was damaged prior to patient use. Although the handle was squeezed, the cartridge jaws were unable to close on the tissue. The jaws could not be closed, and the handle returned to its original position. It was noted that the issue occurred on three handles. A new handle was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819465 ↗
• MalfunctionAug 27, 2026Misfire

  According to the reporter, during a robot-assisted distal pancreatectomy, occurring during pancreatic parenchymal resection, the firing stopped at about 1 cm as the handle could not be squeezed. The issue was resolved by using a new stapler and performing additional resection. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50465949 ↗
• MalfunctionAug 26, 2026Difficult to Open or Close

  According to the reporter, preoperatively, the reload did not move during the loading opening and closing checking using a manual handle. To resolve the issue, the same handle was used and the cartridge was replaced. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50446347 ↗
• MalfunctionAug 13, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50231986 ↗
• MalfunctionAug 12, 2026Misfire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219846 ↗
• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT DURING SETUP, A 60 MM THICK REINFORCED RELOAD USED WITH A MANUAL HANDLE WOULD NOT LOAD. THE HEALTHCARE PROFESSIONAL STATED THAT THE HANDLE AND RELOAD APPEARED TO HAVE MANUFACTURING DEFECTS AND INDICATED THAT THE RELOAD WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 25576241 ↗
• MalfunctionApr 23, 2026Failure to Fire; Expulsion; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING DISTAL PANCREATECTOMY, AT THE TIME OF PANCREATIC RESECTION. THE STAPLER FAILED TO FIRE. MANUAL SUTURING WAS DONE TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT THE OPERATION TIME WAS EXTENDED BY 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24962388 ↗
• MalfunctionApr 22, 2026Failure to Fire; Expulsion; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING DISTAL PANCREATECTOMY, AT THE TIME OF PANCREATIC RESECTION. THE STAPLER FAILED TO FIRE. MANUAL SUTURING WAS DONE TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT THE OPERATION TIME WAS EXTENDED BY 30 MINUTES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953511 ↗
• MalfunctionApr 14, 2026Entrapment of Device; Retraction Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN (HPB) HEPATOBILIOPANCREATIC, DISTAL PANCREATECTOMY AND SPLENECTOMY SURGICAL PROCEDURE, AN UNDEFINED ADAPTER ERROR, ISSUES AFTER FIRING, AND DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT. THE YELLOW CAUTION ERROR APPEARED ON THE SCREEN WITH AN ADAPTER ERROR AND AN ARROW INDICATING TO REMOVE THE RELOAD WHILE THE DEVICE WAS STILL CLAMPED ON TISSUE. THIS OCCURRED DURING FIRING WHILE ATTEMPTING TO RETRACT THE KNIFE BLADE, WHICH MOVED FORWARD AND BACKWARD ABOUT 2 CM. DISCONNECTING THE HANDLE DID NOT RESOLVE THE ISSUE. A RESET OF THE POWER HANDLE ULTIMATELY ALLOWED RETRACTION OF THE KNIFE BLADE AND REMOVAL OF THE STAPLER FROM THE TISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. FROM SR-60903206 - DUPLICATE OF PE 709009542.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24871685 ↗
• MalfunctionApr 12, 2026Failure to Fire

  IT WAS REPORTED THAT DURING USE OF THE STAPLER, THE HANDLE FAILED TO FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE, AND THE DEVICE JAMMED. THE DEVICE WAS REPLACED BY USING ANOTHER NEW HANDLE AND RELOAD WITH THE SAME LOT NUMBER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24853000 ↗
• MalfunctionApr 7, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A PARTIAL PULMONARY RESECTION, WHEN CLAMPING THE LUNG PARENCHYMA, THE JAWS DID NOT CLOSE COMPLETELY. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800173 ↗
• MalfunctionApr 1, 2026Mechanics Altered

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE STAPLES DID NOT DEPLOY, RESULTING IN A CUT BUT NO STAPLES. IT WAS NOTED THAT TWO RELOADS WERE USED AND HAD THE SAME ISSUE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24758342 ↗
• MalfunctionApr 1, 2026Mechanics Altered

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE STAPLES DID NOT DEPLOY, RESULTING IN A CUT BUT NO STAPLES. IT WAS NOTED THAT TWO RELOADS WERE USED AND HAD THE SAME ISSUE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 24758300 ↗
• MalfunctionMar 21, 2026Break; Device Difficult to Setup or Prepare; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PULMORRHAPHY, THERE WAS A CRACK AT THE BASE/PROXIMAL PART OF THE LOCK RING. AFTER PULLING IT UP, IT SLIPPED/SLIDE DOWN WHEN IT WAS RETURNED TO ITS ORIGINAL POSITION. THE LOCK RING WAS OUT OF POSITION. A NEW HANDLE WAS TAKEN OUT, AND THE CONNECTION WITH THE RELOAD WAS CHECKED. SINCE THE CONNECTION WAS NOT POSSIBLE, A NEW RELOAD WAS PROVIDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24656705 ↗
• MalfunctionMar 19, 2026Break; Firing Problem

  IT WAS REPORTED DURING A MAZE PROCEDURE, IN THE LEFT ATRIAL APPENDAGE RESECTION, THE FIRING WAS DIFFICULT, BUT IT WAS POSSIBLE TO COMPLETE THE FIRING TO THE END. NO INTERVENTION WAS DONE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE CLAMPING MECHANISM WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640386 ↗
• MalfunctionMar 18, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT UPPER LOBE RESECTION, THE FIRING STOPPED MIDWAY. TO RESOLVE THE ISSUE, THE HANDLE WAS REPLACED, AND THEN THE FIRING WAS DONE USING THE SAME CARTRIDGE, BUT BECAUSE IT WAS NOT POSSIBLE AFTERWARDS, THE CARTRIDGE WAS ALSO REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 24628927 ↗
• MalfunctionMar 3, 2026Failure to Fire

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING A PANCREATIC RESECTION, THE GREEN BUTTON WAS PRESSED BUT THE POWERED STAPLER DID NOT FIRE. THE RELOAD WAS RECONNECTED BUT THE SAME ISSUE OCCURRED. ANOTHER RELOAD WAS USED WITH THE SAME POWERED HANDLE AND ADAPTER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493788 ↗
• MalfunctionFeb 26, 2026Misfire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 6 CM TUMOR, THREE HANDLES AND ONE RELOAD WERE DIFFICULT TO FIRE, RESULTING IN AN EXTENDED SURGICAL TIME. THE SURGEON USED MULTIPLE CARTRIDGES BECAUSE THE DEVICE COULD NOT BE FULLY ACTIVATED. WHEN THE CARTRIDGE WAS CLOSED ON THE LUNG, THE ANVIL BOUNCED BACK. IT WAS NOTED THAT THE HANDLE WAS CRACKING. THE DEVICE WAS REPLACED TWICE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED. STAPLE PUSHERS WERE VISIBLE AT THE 3CM CUT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24461504 ↗
• MalfunctionFeb 26, 2026Misfire; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A 6 CM TUMOR, THREE HANDLES AND ONE RELOAD WERE DIFFICULT TO FIRE, RESULTING IN AN EXTENDED SURGICAL TIME. THE SURGEON USED MULTIPLE CARTRIDGES BECAUSE THE DEVICE COULD NOT BE FULLY ACTIVATED. WHEN THE CARTRIDGE WAS CLOSED ON THE LUNG, THE ANVIL BOUNCED BACK. IT WAS NOTED THAT THE HANDLE WAS CRACKING. THE DEVICE WAS REPLACED TWICE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RELOAD WAS PARTIALLY FIRED WITH THE INTERLOCK ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24456599 ↗
• MalfunctionFeb 25, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A BULLECTOMY, THE FIRING COULD NOT BE PERFORMED AT ALL. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS NOT ABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24447338 ↗
• MalfunctionFeb 23, 2026Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, AFTER PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZED AND THE 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 24414590 ↗
• MalfunctionFeb 19, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A DISTAL PANCREATECTOMY, WHILE ON PANCREATIC RESECTION, THE FIRING COULD NOT BE DONE AT ALL. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON. A NEW CARTRIDGE WAS USED WITH THE SAME HANDLE TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397689 ↗
• MalfunctionFeb 17, 2026Misfire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE HANDLES BROKE AND CRACKED. THE SURGEON ATTEMPTED MULTIPLE RELOADS AND WENT FROM PURPLE TO BLACK ON THE ANTRUM OF THE STOMACH, YET THE SURGEON COULD NOT FIRE THROUGH ONE AREA OF THE STOMACH; IT WAS PARTIALLY FIRED. AFTER MULTIPLE ATTEMPTS, THE SURGEON MOVED LATERAL AND COMPLETED THE SLEEVE WITH NO ISSUES. THE SURGEON OVERSEWED THE STAPLE LINE AT THE AREA.

  Patient problems: Tissue Breakdown

  MAUDE report 24372947 ↗
• MalfunctionFeb 17, 2026Misfire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE HANDLES BROKE AND CRACKED. THE SURGEON ATTEMPTED MULTIPLE RELOADS AND WENT FROM PURPLE TO BLACK ON THE ANTRUM OF THE STOMACH, YET THE SURGEON COULD NOT FIRE THROUGH ONE AREA OF THE STOMACH; IT WAS PARTIALLY FIRED. AFTER MULTIPLE ATTEMPTS, THE SURGEON MOVED LATERAL AND COMPLETED THE SLEEVE WITH NO ISSUES. THE SURGEON OVERSEWED THE STAPLE LINE AT THE AREA.

  Patient problems: Tissue Breakdown

  MAUDE report 24372920 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173270. One submission often covers many models, so check the product and lot details in each record.

• Z-1419-2021 · Mar 23, 2021 · Terminated
  Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple line reinforcement has applications in abdominal, gynecologic,