Tri-Staple 2.0 SIGTRSB60AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 778 adverse event reports that list this exact device (DI 10884521717626), received between Dec 13, 2018 and Sep 28, 2026 — classified as 102 injuries, 676 malfunctions.

The most frequently reported specific device problem is “Misfire” (282 reports).

2 other recalls 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. 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 778 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Misfire

  According to the reporter, during the laparoscopic assisted distal gastrectomy, when applied at the stomach, partial firing occurred midway. A new cartridge was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914909 ↗
• MalfunctionSep 23, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863109 ↗
• MalfunctionSep 22, 2026Detachment of Device or Device Component; Mechanics Altered

  Patient problems: Insufficient Information

  MAUDE report 50860202 ↗
• MalfunctionAug 26, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461140 ↗
• MalfunctionAug 12, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50217401 ↗
• MalfunctionJun 4, 2026Misfire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PARTIAL RESECTION, THERE WAS NO PROBLEM AT THE FIRST FIRING, BUT WHEN THE PURPLE CARTRIDGE WAS USED WITH A REINFORCED SHEET, THERE WAS A CRACKING SOUND, AND FIRING STOPPED HALFWAY THROUGH. A NEW HANDLE WAS TAKEN OUT TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25396214 ↗
• MalfunctionJun 1, 2026Retraction Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE SECOND-TO-LAST FIRING RELEASED MORE SLOWLY THAN NORMAL. AFTER FIRING, THE DEVICE WOULD NOT ARTICULATE BACK TO THE NEUTRAL POSITION. AN ARROW INDICATOR WAS OBSERVED IN THE RELOAD LANE AREA ON THE POWERED HANDLE, AND THERE WAS DIFFICULTY RETRACTING THE KNIFE BLADE AFTER FIRING. AS A RESULT, THE PROCEDURE TIME WAS EXTENDED BY APPROXIMATELY 10 MINUTES AND ANOTHER ADAPTER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25345740 ↗
• MalfunctionMay 12, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE RELOAD COMPONENT BROKE, SPECIFICALLY AT THE ARTICULATION JOINT, CAUSING PIECES TO FALL INTO THE PATIENT CAVITY. AN X-RAY WAS REQUIRED TO LOCATE THE COMPONENTS WITHIN THE PATIENT CAVITY. THE PIECES WERE SUCCESSFULLY RETRIEVED THROUGH A LAPAROSCOPIC INTERVENTION. A SCAN WAS CONDUCTED ON THE PATIENT AS PART OF THE PROCEDURE. THE EVENT RESULTED IN AN EXTENDED HOSPITALIZATION FOR THE PATIENT. THE PRODUCT WAS RETURNED WITHOUT ACCOMPANYING INFORMATION. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE BLOWOUT PLATE ON THE NON-ARTICULATION FLAG SIDE WAS RETURNED DISENGAGED FROM THE RELOAD.

  Patient problems: Insufficient Information

  MAUDE report 25155663 ↗
• MalfunctionMay 8, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE RELOAD COMPONENT BROKE, SPECIFICALLY AT THE ARTICULATION JOINT, CAUSING PIECES TO FALL INTO THE PATIENT CAVITY. AN X-RAY WAS REQUIRED TO LOCATE THE COMPONENTS WITHIN THE PATIENT CAVITY. THE PIECES WERE SUCCESSFULLY RETRIEVED THROUGH A LAPAROSCOPIC INTERVENTION. A SCAN WAS CONDUCTED ON THE PATIENT AS PART OF THE PROCEDURE. THE EVENT RESULTED IN AN EXTENDED HOSPITALIZATION FOR THE PATIENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE.

  Patient problems: Insufficient Information

  MAUDE report 25129338 ↗
• MalfunctionApr 27, 2026Difficult to Open or Close

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC COLECTOMY, DURING INTESTINAL RESECTION, AFTER PERFORMING AN EXTRACORPOREAL RESECTION (A NASTOMOSIS) OF THE INTESTINE, THE SURGEON PRESSED THE UPPER BUTTON ON THE CENTER CONTROL TO OPEN THE TIP OF THE CARTRIDGE, BUT IT FAILED TO OPEN. THE CARTRIDGE FROM THE TISSUE WAS RELEASED, BUT IT REMAINED CLOSED. THE CARTRIDGE WAS REMOVED AND ONLY THE ADAPTER WAS REPLACED WITH A NEW ONE. SUBSEQUENTLY, THE HANDLE COULD BE OPERATED WITHOUT PROBLEMS USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000583 ↗
• MalfunctionApr 24, 2026Material Rupture; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE, AFTER FIRING, THE TWO RELOADS DID NOT PERFORM A COMPLETE CUT AND THE RELOAD REINFORCEMENT MATERIAL DETACHED/LOOSENED, WITH THE REINFORCEMENT MATERIAL REPORTED AS TORN OR DAMAGED. NEW RELOADS WERE USED TO CONTINUE THE CASE, AND THE DEVICE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 24988366 ↗
• MalfunctionApr 24, 2026Material Rupture; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE, AFTER FIRING, THE TWO RELOADS DID NOT PERFORM A COMPLETE CUT AND THE RELOAD REINFORCEMENT MATERIAL DETACHED/LOOSENED, WITH THE REINFORCEMENT MATERIAL REPORTED AS TORN OR DAMAGED. NEW RELOADS WERE USED TO CONTINUE THE CASE, AND THE DEVICE WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 24988066 ↗
• 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 24953738 ↗
• 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. IT WAS ALSO NOTED THAT THERE WERE STAPLES NEAR THE BASE OF THE JAW OF THE CARTRIDGE AND THE HANDLE WAS IDLING. 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 24953495 ↗
• MalfunctionApr 16, 2026Material Rupture; Misfire

  ACCORDING TO THE REPORTER, DURING A GASTRECTOMY VERTICAL WITH NISSEN, PRIOR TO PATIENT USE, THE REINFORCEMENT MATERIAL WAS CUT AT THE MOMENT THE RELOAD WAS OPENED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS 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 24895686 ↗
• MalfunctionApr 16, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RELOAD FIRED HALFWAY, LEAVING ONE-THIRD OF THE STAPLE LINE UNFINISHED. A NEW REINFORCED RELOAD WAS USED WITH THE SAME POWERED HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24894216 ↗
• MalfunctionApr 13, 2026Misfire; No Apparent Adverse Event

  DUPLICATE OF (B)(4).

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

  MAUDE report 24867087 ↗
• MalfunctionApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADJUSTABLE GASTRIC BAND AND SUBCUTANEOUS PORT REMOVAL, AS WELL AS A LAPAROSCOPIC PARTIAL GASTRECTOMY ROUX-EN-Y WITH INTRAOPERATIVE ENDOSCOPY, STAPLE LINE BLEEDING WAS OBSERVED FROM THE REMNANT STOMACH AFTER 20 MINUTES OFFIRING A PURPLE REINFORCEMENT RELOAD. THE SAME ISSUE OCCURRED ON ANOTHER PURPLE RELOAD. ADDITIONALLY, FROM THE STAPLE LINE AT THE JEJUNUM AFTER 20 MINUTES OF FIRING A CURVED TIP TAN LOAD, THE SAME ISSUE OCCURRED. SUTURING WAS PERFORMED AS A STAPLE LINE REINFORCEMENT TO RESOLVE THE ISSUE. IT WAS NOTED THAT THE SURGICAL PROCEDURE WAS EXTENDED BY ABOUT 30 MINUTES.

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

  MAUDE report 24848370 ↗
• MalfunctionApr 8, 2026Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC BYPASS SLEEVE, DURING THE TRANSECTION OF THE STOMACH, THE POWERED STAPLER PARTIALLY FIRED. THE FIRING STOP HALF WAY THROUGH THE FIRING. THE STAPLE LINE WAS RESECTED AND RE-STAPLED DUE TO THE ISSUE. THE ISSUE HAPPENED WITH FOUR RELOADS.

  Patient problems: Tissue Breakdown

  MAUDE report 24812907 ↗
• MalfunctionApr 8, 2026Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC BYPASS SLEEVE, DURING THE TRANSECTION OF THE STOMACH, THE POWERED STAPLER PARTIALLY FIRED. THE FIRING STOP HALF WAY THROUGH THE FIRING. THE STAPLE LINE WAS RESECTED AND RE-STAPLED DUE TO THE ISSUE. THE ISSUE HAPPENED WITH FOUR RELOADS.

  Patient problems: Tissue Breakdown

  MAUDE report 24812894 ↗
• MalfunctionApr 7, 2026Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC GASTRIC BYPASS SLEEVE, DURING THE TRANSECTION OF THE STOMACH, THE POWERED STAPLER PARTIALLY FIRED. THE FIRING STOP HALF WAY THROUGH THE FIRING. THE STAPLE LINE WAS RESECTED AND RE-STAPLED DUE TO THE ISSUE. THE ISSUE HAPPENED WITH FOUR RELOADS.

  Patient problems: Tissue Breakdown

  MAUDE report 24809183 ↗
• MalfunctionApr 6, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING OPEN SURGERY, THE METAL PRODUCING THE CLICKING SOUND OF THE LF1923 WAS DETACHED AND DROPPED OUTSIDE THE SURGICAL FIELD AND DID NOT FELL INTO THE PATIENT CAVITY. THE BROKEN PIECE WAS REMOVED. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE CLAMPING MECHANISM WAS DEFORMED DUE TO THICK TISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24789929 ↗
• MalfunctionApr 6, 2026Misfire; Separation Failure

  IT WAS REPORTED THAT DURING A PROCEDURE, THE REINFORCEMENT MATERIAL (TRS) DID NOT RELEASE FROM THE STAPLER AFTER COMPLETION OF FIRING. SCISSORS WERE USED TO CUT THE REINFORCEMENT FROM THE STAPLER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT ALL THE RELOAD PUSHERS WERE FIRED, HOWEVER, THE SLED WAS NOT FULLY ADVANCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789362 ↗
• MalfunctionApr 3, 2026Failure to Read Input Signal; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE CARTRIDGE DID NOT FIT IN THE LOADER AND THE OTHER CARTRIDGE WOULD NOT READ. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24783041 ↗
• MalfunctionApr 3, 2026Failure to Read Input Signal; Failure to Fire; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, ONE CARTRIDGE DID NOT FIT IN THE LOADER AND THE OTHER CARTRIDGE WOULD NOT READ. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 24782924 ↗

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-1891-2024 · Apr 15, 2024 · Open, Classified
  Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anas
• 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,