Tri-Staple 2.0 SIG60CTAMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10884521543683), received between Apr 18, 2018 and Dec 16, 2025 — classified as 14 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (22 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, THE RELOAD EXPERIENCED SET-UP ISSUES PRIOR TO FIRING, THE JAWS WILL NOT OPEN AT ALL. A NEW 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 23816195 ↗
• MalfunctionDec 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A PROCEDURE, THE INSTRUMENT DID NOT FIRE. A NEW HANDLE STAPLER AND RELOAD WERE 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 23800466 ↗
• MalfunctionNov 13, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BRONCHOSCOPY VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), THE INSTRUMENT DID NOT FIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550089 ↗
• MalfunctionNov 13, 2025Difficult to Open or Close; Insufficient Device Problem Information; Difficult to Open or Close; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER DURING A ROBOT-ASSISTED PANCREATICODUODENECTOMY, THE CARTRIDGE WAS CONNECTED AND TRIED TO FIRE, BUT THE GREEN BUTTON DID NOT LIGHT UP AND THE FIRING COULD NOT BE DONE. WHEN THE CARTRIDGE WAS TAKEN OUT FROM THE OUTSIDE SURGICAL FIELD, THE JAW COULD NOT BE OPENED. THE NURSE MANAGED TO DETACH IT FROM THE ADAPTER AND CONNECTED ANOTHER CARTRIDGE AND IT WAS ABLE TO BE USED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541454 ↗
• MalfunctionAug 1, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, BEFORE A LAPAROSCOPIC PARTIAL HEPATECTOMY, THE DEVICE DID NOT FIRE AT ALL. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED WITH THE SAME HANDLE AND ADAPTER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688945 ↗
• MalfunctionJul 15, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC ESOPHAGEAL RESECTION, THE FIRING STOPPED NEAR THE 4 CM OF THE SCALE. ALTHOUGH IT STOPPED MIDWAY THE FIRED STAPLE WAS DEPLOYED WITHOUT ANY PROBLEM, SO IT WAS REPLACED WITH A NEW ONE THAT HAD BEEN PREPARED. WHEN TRIED TO PERFORM FIRING AGAIN FROM THE POINT WHERE IT STOPPED, WAS ABLE TO PERFORM FIRING TO THE END THIS TIME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505417 ↗
• MalfunctionJun 20, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING AN ESOPHAGEAL RESECTION, FIRING COULD NOT BE DONE. THE USER REPLACED WITH A NEW CARTRIDGE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296197 ↗
• MalfunctionFeb 18, 2025Break; Device Displays Incorrect Message; Break; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LUNG RESECTION, WHEN THE CARTRIDGE WAS CONNECTED, THE SCREEN SHOWED A YELLOW EXCLAMATION MARK ABOVE THE RELOAD SWIMLANE, AND IT COULD NOT BE USED. EVEN AFTER RECONNECTING, THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, A NEW CARTRIDGE MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT TWO STAPLES COULD BE SEEN PARTIALLY PROTRUDING FROM THE PROXIMAL END OF THE STAPLE CARTRIDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21399912 ↗
• MalfunctionFeb 7, 2025Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A THORACIC LUNG RESECTION PROCEDURE, THE RELOAD WAS NEW, BUT WINDOW ON POWERED HANDLE INDICATED ZERO LIVES FOR THE RELOAD, AS THOUGH THE RELOAD HAD BEEN FIRED. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE CLAMPING MECHANISM WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21336065 ↗
• MalfunctionJan 15, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, WHEN BEFORE THE LUNG WAS RESECTED, THE FIRING STOPPED PARTIALLY. IT WAS NOTED THAT THE KNIFE BLADE WAS RETRACTED. A NEW RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157453 ↗
• MalfunctionJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LOBECTOMY (UPPER LOBE, LOWER LOBE), AFTER THE FIRING THERE WAS LEAK FROM THE STAPLE LINE, IT WAS A MINOR ANASTOMOTIC LEAK. CONFIRMATION USING AIR BUBBLES/METHYLENE BLUE. THE LEAK SITE WAS SUTURED DURING THE SUTURING, THERE WERE MOMENTS WHEN THE LUNG WAS AVOIDED.

  Patient problems: Failure to Anastomose

  MAUDE report 21091072 ↗
• MalfunctionJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LOBECTOMY (UPPER LOBE, LOWER LOBE), AFTER THE FIRING THERE WAS LEAK FROM THE STAPLE LINE, IT WAS A MINOR ANASTOMOTIC LEAK. CONFIRMATION USING AIR BUBBLES/METHYLENE BLUE. THE LEAK SITE WAS SUTURED DURING THE SUTURING, THERE WERE MOMENTS WHEN THE LUNG WAS AVOIDED.

  Patient problems: Failure to Anastomose

  MAUDE report 21090971 ↗
• MalfunctionJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING A THORACOSCOPIC LOBECTOMY (UPPER LOBE, LOWER LOBE), AFTER THE FIRING THERE WAS LEAK FROM THE STAPLE LINE, IT WAS A MINOR ANASTOMOTIC LEAK. CONFIRMATION USING AIR BUBBLES/METHYLENE BLUE. THE LEAK SITE WAS SUTURED DURING THE SUTURING, THERE WERE MOMENTS WHEN THE LUNG WAS AVOIDED.

  Patient problems: Failure to Anastomose

  MAUDE report 21090646 ↗
• InjurySep 12, 2024Misfire; Detachment of Device or Device Component; Misfire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY REVISION, ON STOMACH STAPLING, THE FIRST LOAD USED WAS UNABLE TO FIRE. THE SECOND AND THIRD LOADS FIRED FINE. THE FOURTH LOAD EXPERIENCED A PARTIAL FIRING. AFTER THE PARTIAL FIRING THERE WAS A LOOSE STAPLE SEEN IN THE PATIENT'S ABDOMINAL CAVITY. EITHER FROM THE STAPLER CARTRIDGE OR A PREVIOUS FIRING. THE USER REMOVED THE STAPLES USING A LAPAROSCOPIC GRASPER. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY 45 MINUTES. THE PHYSICIAN REQUESTED USE OF A DIFFERENT DEVICE AND THAT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207825 ↗
• InjurySep 12, 2024Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY REVISION, ON STOMACH STAPLING, THE FIRST LOAD USED WAS UNABLE TO FIRE. THE SECOND AND THIRD LOADS FIRED FINE. THE FOURTH LOAD EXPERIENCED A PARTIAL FIRING. AFTER THE PARTIAL FIRING THERE WAS A LOOSE STAPLE SEEN IN THE PATIENT'S ABDOMINAL CAVITY. EITHER FROM THE STAPLER CARTRIDGE OR A PREVIOUS FIRING. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY 45 MINUTES. THE PHYSICIAN REQUESTED USE OF A DIFFERENT DEVICE AND THAT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20207441 ↗
• MalfunctionJul 22, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A ROBOT ASSISTED THORACOSCOPIC LOBECTOMY PROCEDURE, THE JAW OF THE RELOAD COULD NOT BE OPENED INSIDE THE ABDOMINAL CAVITY. ANOTHER RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, THE JAWS WERE OPENED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794189 ↗
• MalfunctionJul 22, 2024Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING A ROBOT ASSISTED THORACOSCOPIC LOBECTOMY PROCEDURE, THE JAW OF THE RELOAD COULD NOT BE OPENED INSIDE THE ABDOMINAL CAVITY. ANOTHER RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED. TO RESOLVE THE ISSUE, THE JAWS WERE OPENED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19793428 ↗
• MalfunctionJul 18, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE FIRED HALFWAY AND WOULD NOT FIRE THE REMAINING HALF. A NEW BLACK RELOAD WAS USED WITH THE SAME POWERED DEVICES TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19778304 ↗
• MalfunctionJun 25, 2024Misfire; Expulsion; Misfire; Expulsion

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOT-ASSISTED INFERIOR ESOPHAGECTOMY, DURING GASTRIC TUBE FORMATION, ON THE 7TH OR 8TH FIRING FROM THE BEGINNING, WHEN THE CARTRIDGE WAS LOADED, IT WAS DISCOVERED THAT THE STAPLES WERE ALREADY EXPOSED AT THE PROXIMAL SIDE WITHIN THE ABDOMINAL CAVITY BEFORE PERFORMING THE FIRING OPERATION. A NEW CARTRIDGE WAS ATTACHED WITH THE SAME HANDLE AND ADAPTER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RELOAD WAS PARTIALLY FIRED AND THE INTERLOCK WAS ENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606236 ↗
• MalfunctionJun 18, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LUNG LOBECTOMY OF THE RIGHT MIDDLE LOBE, THE HANDLE FAILED TO TRIGGER THE RELOAD WHEN RESECTING THE LUNG TISSUE. A NEW HANDLE WAS USED WITH THE SAME RELOAD HOWEVER THE ISSUE PERSISTS. ANOTHER HANDLE AND RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19560556 ↗
• MalfunctionMay 13, 2024Failure to Form Staple; Detachment of Device or Device Component; Failure to Form Staple; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RIGHT LOWER LOBECTOMY, WHEN THE SURGEON WAS STAPLING THE BRONCHUS OF THE RIGHT LOWER LUNG, THE SURGEON FIRED THE DEVICE WITH THE GRAY TOGGLE BUTTON UNTIL COMPLETE, BUT THERE WAS POOR STAPLE FORMATION. PART OF THE RELOAD FIRED IN THE CORRECT STAPLE FORMATION, BUT A PORTION OF THE FIRED STAPLES DID NOT FORM. THE STAPLES DEPLOYED IN THE UNFORMED SHAPE. THE CLEAR PUSHERS WERE VISIBLE AT THE BEGINNING OF THE RELOAD, CLOSEST TO THE HINGE, AND THERE WERE EXCESS PROPER B-SHAPED STAPLES, BUT THEN IN THE MIDDLE OF THE RELOAD THERE WERE PARTIAL DEPLOYMENT OF STAPLES THAT DID NOT FORM AT ALL. THE RELOAD ALSO DID NOT CUT AT THE DISTAL END. THE STAPLE LINE WAS INCOMPLETE DISTALLY. A FEW STAPLES FELL AND WERE SCATTERED AROUND THE STAPLE LINE. AN ADDITIONAL RELOAD WAS USED TO FINISH THE TRANSECTION AT THE DISTAL END. SEVERAL OTHER RELOADS WERE FIRED AND USED WITH SAME HANDLE AND ADAPTER AND HAD NO ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 19305824 ↗
• MalfunctionMay 1, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC RECTAL RESECTION, DURING THE ATTEMPT TO FIRE, THE DEVICE DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND  SQUEEZE THE HANDLE, BUT THE DEVICE DID NOT FIRE. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219115 ↗
• MalfunctionFeb 1, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, AFTER PRESSING THE GREEN BUTTON; THE HANDLE COULD NOT BE SQUEEZE AND THE DEVICE DID NOT FIRE. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628767 ↗
• MalfunctionOct 5, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC THORACOSCOPIC PULMONARY MALIGNANT TUMOR SURGERY, ON PULMONARY PARENCHYMA (BETWEEN SEGMENT) RESECTION, THERE WAS NO PROBLEM IN THE CONNECTION, THE GREEN BUTTON COULD BE PRESSED, BUT THE FIRING COULD NOT BE DONE. 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 17882351 ↗
• MalfunctionJul 28, 2023Entrapment of Device; Retraction Problem; Entrapment of Device; Retraction Problem

  ACCORDING TO THE REPORTER, IN A VIDEO-ASSISTED THORACIC SURGERY (VATS) LOBECTOMY, WHEN IN THE PULMONARY ARTERY BRANCH IN LUNG, THE 60MM PURPLE CURVED TIP RELOAD WAS FIRED CORRECTLY BUT THE JAWS OF THE DEVICE WOULD NOT OPEN AND LOCKED ON THE TISSUE. THE BLACK LEVER THAT WAS USED TO OPEN THE JAWS WAS STUCK AND EXCESSIVE FORCE HAD TO BE USED TO OPEN THE JAWS. THE JAWS WERE OPENED WITH NO ISSUES. THE SURGEON SPENT ABOUT 15 MINUTES OF TRIAL AND ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420356 ↗

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-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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• 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-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• 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-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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• 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