Tri-Staple 2.0 SIG45CTAMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 80 adverse event reports that list this exact device (DI 10884521543713), received between May 9, 2018 and Sep 12, 2026 — classified as 8 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (24 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 80 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2026Entrapment of Device; Retraction Problem; Detachment of Device or Device Component

  Patient problems: Tissue Breakdown

  MAUDE report 50745019 ↗
• MalfunctionJul 13, 2026Retraction Problem; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25798020 ↗
• MalfunctionMar 19, 2026Misfire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, THE DEVICE DID NOT FIRE COMPLETELY. ANOTHER RELOAD WAS OPENED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24643761 ↗
• MalfunctionMar 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PULMONARY LOBECTOMY, THE TWO BLACK 60MM RELOADS FAILED IN THE PARENCHYMA. AFTER STAPLING, THE STAPLE LINE WAS OBSERVED TO BE POORLY FORMED (INCOMPLETE CENTRALLY); THE STAPLES WERE NOT PERFECTLY ALIGNED AS THE STAPLE FORMATION WAS NOT FORMED CORRECTLY IN THE B SHAPE. THE PURPLE 45MM RELOAD WAS USED IN THE BRONCHUS, IT WAS STAPLED BUT AFTER A FEW MINUTES THE STAPLE LINE OPENED UP. TROUBLESHOOTING INVOLVED REPLACING THE RELOADS, WHICH WERE FROM THE SAME BATCH AS THE ONES REPLACED, AND USING THE SAME ADAPTER AND HANDLE. AFTER REPLACEMENT, THE STAPLE LINE WAS PROPERLY STAPLED. THE PROCEDURE WAS EXTENDED BY 45 MINUTES AS A RESULT.

  Patient problems: Tissue Breakdown

  MAUDE report 24597002 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY, IMMEDIATELY AFTER FIRING, THE SURGEON LEFT THE VISUAL FIELD OF THE SECTIONED BRONCHUS AND RETIRED SOME GANGLIONS. WHEN THE SURGEON WAS BACK TO THE FIELD OF THE BRONCHUS, THE STAPLE LINE HAVE BECOME OPENED. THIS LED TO THE CONVERSION TO AN OPEN SURGERY, EXTENDING SURGICAL TIME BY 60 MINUTES, AND REQUIRING SUTURING AS A REPLACEMENT FOR THE STAPLE LINE. THE PATIENT NEEDED EXTENDED HOSPITALIZATION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT.

  Patient problems: Laceration(s); Tissue Breakdown

  MAUDE report 24551872 ↗
• MalfunctionFeb 18, 2026Misfire

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE STAPLE CARTRIDGE WAS LOADED ONTO STAPLER, THE TEST WAS FINE AND FUNCTIONAL. HOWEVER, THE STAPLER PARTIALLY FIRE, THE STAPLE STOPPED WORKING WHEN ON THE VESSEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378035 ↗
• InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON THE (B)(6) 2026, THE FIRST POSTOPERATIVE DAY OF AN UPPER LOBE LOBECTOMY, STAPLES WERE OPENED AND A LEAK WAS NOTICED ON THE MAIN BRONCHUS OF THE LEFT LUNG. THE LEAK WAS IDENTIFIED AT THE STAPLE LINE CREATED WITH THE RELOAD. ADDITIONAL SURGERY WAS REQUIRED TO REPAIR THE LEAK, DURING WHICH SUTURING WAS PERFORMED AS A STAPLE LINE REPLACEMENT.

  Patient problems: Tissue Breakdown

  MAUDE report 24338333 ↗
• MalfunctionFeb 12, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LEFT COLECTOMY, THE FIRST STAPLING WORKED; HOWEVER, FOR THE SECOND STAPLING, IT WAS IMPOSSIBLE TO ACTUATE THE HANDLE. 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 24327716 ↗
• MalfunctionJan 30, 2026Break; Entrapment of Device; Retraction Problem; Unintended Movement; Noise, Audible

  ACCORDING TO THE REPORTER, DURING A ROBOTIC ANTERIOR SEGMENTECTOMY WITH GLISSON EN BLOC RESECTION, A POWER HANDLE WITH A STANDARD ADAPTER AND CARTRIDGE WAS IN USE WHEN, DURING NEEDLE INSERTION, AN ABNORMAL MECHANICAL NOISE WAS NOTED AND THE DEVICE ARTICULATED UNINTENTIONALLY, AFTER WHICH THE KNIFE FAILED TO RETURN AND THE JAWS COULD NOT OPEN OR MOVE FORWARD OR BACKWARD, RESULTING IN TISSUE BEING CLAMPED AND UNABLE TO BE RELEASED. MULTIPLE TROUBLESHOOTING STEPS WERE ATTEMPTED INTRAOPERATIVELY, INCLUDING RESTARTING THE HANDLE, RECONNECTING COMPONENTS, CALIBRATION ATTEMPTS, USE OF A MANUAL ADAPTER TOOL, AND REPLACEMENT OF THE HANDLE AND SHELL, ALL WITHOUT RESOLUTION, LEADING TO AN EXTENDED OPERATIVE TIME OF APPROXIMATELY THREE HOURS, AND ULTIMATELY THE ISSUE WAS RESOLVED BY APPLYING A POLYMER LOCKING LIGATION SYSTEM ON THE PATIENT SIDE AND DISSECTING THE TISSUE WITH SCISSORS, WHILE THE SPECIMEN SIDE WAS DIVIDED USING A MONOPOLAR INSTRUMENT, ALLOWING SAFE RELEASE OF THE TISSUE AND COMPLETION OF THE PROCEDURE. THE PATIENT OUTCOME WAS NOTED AS PROLONGED OPERATIVE TIME ONLY, WITH THE CARTRIDGE REMAINING CONNECTED TO THE ADAPTER AND PLANNED FOR CLEANING AND STERILIZATION, AND SUBSEQUENT EV

  Patient problems: Tissue Breakdown

  MAUDE report 24220039 ↗
• MalfunctionJan 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING A PROCEDURE, THE JAWS DID NOT CLOSE COMPLETELY SO THE STAPLER DID NOT FIRE AS EXPECTED. SEVERAL TIMES, THE SURGEON CLOSED THE RELOADS ON DIFFERENT TYPES OF TISSUE, INCLUDING LUNG PARENCHYMA, VESSEL, AND BRONCHUS, BUT THE EXPECTED FIRING THICKNESS INDICATORS DID NOT APPEAR ON THE SCREEN, AND IT SEEMED THAT THE JAWS DID NOT CLOSE PROPERLY. MULTIPLE ATTEMPTS WERE REQUIRED TO ACHIEVE PROPER DEVICE FUNCTION, AND SOMETIMES AFTER TWO OR THREE TRIES, THE ISSUE WAS RESOLVED AND THE DEVICE FIRED AS INTENDED. HOWEVER, THESE DIFFICULTIES OCCURRED REPEATEDLY IN TWO DIFFERENT PROCEDURES ON THE SAME DAY. TROUBLESHOOTING STEPS INCLUDED CHANGING THE POWER HANDLE, SHELL, AND RELOADS, BUT THE ISSUE PERSISTED. THE POWER HANDLE WAS REPLACED 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 23971440 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A ROBOTIC-ASSISTED THORACOSCOPIC SURGERY (RATS) LOBECTOMY, BEFORE USE ON PATIENT, WHEN IT WAS CONNECTED TO THE ADAPTER, THE CONNECTION PART OF THE LOCK RING ITSELF WAS COMPLETELY DISCONNECTED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23924322 ↗
• MalfunctionNov 26, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE STAPLER WAS FIRED COMPLETELY DOWN ON THE BRONCHUS, AND THERE WAS AN INCOMPLETE STAPLE LINE.

  Patient problems: Tissue Breakdown

  MAUDE report 23659007 ↗
• MalfunctionNov 7, 2025Break; Break

  IT WAS REPORTED THAT DURING THE VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, THE SHIPPING WEDGE BROKE, RESULTING INTO PIECES THAT FELL INTO THE PATIENT CAVITY. ALL PIECES WERE RETRIEVED USING ENDO GRASPERS. THE DEVICE WAS REPLACED WITH ANOTHER RELOAD TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501339 ↗
• MalfunctionOct 27, 2025Misfire; Failure to Form Staple; Failure to Cut; Misfire; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, DURING A BRONCHUS STAPLING, THE FIRING WENT WELL, BUT UPON OPENING AND REMOVING THE POWERED STAPLER, IT TURNED OUT THAT IT DID NOT STAPLE, AND IT DID NOT CUT THE ENTIRE STAPLE LINE PROXIMALLY. SEVERAL LOOSE STAPLES WERE LYING AROUND THE STAPLE LINE, WHICH HAD BEEN FIRED BUT ONLY PARTIALLY CLOSED. THE TISSUE WAS NOT CUT SMOOTHLY AND HAD A JAGGED LINE. THE SURGEON RESECTED AND RESTAPLED THE TISSUE WITH A NEW RELOAD TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 23399510 ↗
• MalfunctionJul 22, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE RELOAD DID NOT FIRE. THE SURGEON WAS ABLE TO PRESS GREEN THE BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE RELOAD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 22571915 ↗
• MalfunctionJun 9, 2025Misfire; Expulsion; Misfire; Expulsion

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, A PRE-FIRE WAS NOTICED WHEN THE CARTRIDGE WAS LOADED INTO THE HANDLE, AND THE CARTRIDGE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THE RELOAD WAS PARTIALLY FIRED AND THE INTERLOCK WAS ENGAGED. THE SLED AND STAPLES WERE VISIBLE AT THE 3CM CUT LINE. STAPLE PUSHERS WERE VISIBLE AT THE 3.5CM CUT LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167797 ↗
• MalfunctionMay 23, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  ACCORDING TO THE REPORTER DURING A THORACIC PROCEDURE, CARTRIDGE WAS NOT FIRING, STICKING WHEN OPENING AND CLOSING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076482 ↗
• MalfunctionMar 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, THE SHIPPING WEDGE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721075 ↗
• MalfunctionMar 28, 2025Break; Break

  ACCORDING TO THE REPORTER, DURING A PULMONARY RESECTION, THE SHIPPING WEDGE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721027 ↗
• MalfunctionJan 31, 2025Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, THE CORRESPONDING RELOAD WAS LOADED INTO THE STAPLER. WHILE LOADING, THE AR ROW ON THE RELOAD SIDE AND THE ARROW ON THE STAPLER SHAFT WERE ALIGNED, AND THE RELOAD WAS PUSHED IN AND ROTATED. AN ATTEMPT WAS THEN MADE TO COMPLETE THE LOADING, BUT IT WAS CONFIRMED THAT THE RELOAD DID NOT ROTATE TO THE END. AS A RESULT, THE RELOAD AND THE HANDLE WERE REMOVED. DURING THIS PROCESS, THE RELOAD WAS PHYSICALLY BROKEN AND PARTS FELL OFF, SO THE RELOAD WAS REPLACED WITH A NEW ONE, AND THE STAPLER WAS USED. THE HANDLE COULD STILL BE USED AS IT WAS, SO IT WAS DETERMINED THAT THERE WERE NO PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283424 ↗
• 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 21090791 ↗
• MalfunctionJan 7, 2025Break; Break

  ACCORDING TO THE REPORTER DURING THE ROBOT ASSISTED LIVER RESECTION, THERE WAS A DAMAGED PART FROM THE RELOAD CONNECTION BEFORE FIRING. THE PRODUCT WAS REPLACED USING THE SAME PRODUCT FROM ANOTHER LOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21090299 ↗
• MalfunctionDec 2, 2024Entrapment of Device; Failure to Form Staple; Mechanics Altered; Entrapment of Device; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LEFT UPPER LOBECTOMY, AFTER FIRING, THE STAPLES MISSED THE ANVIL BUCKETS, CAUSING THEM TO NOT FORM AND GET STUCK IN BRONCHUS STUMP. THE STAPLES WERE STUCK IN THE RELOAD AND TISSUE AFTER FIRING AND HAD TO BE CAREFULLY EXTRACTED. A LEAK TEST WAS DONE MULTIPLE TIMES TO ENSURE THAT THERE WAS NO LEAK ON BRONCHUS STUMP. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20828322 ↗
• MalfunctionSep 11, 2024Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY WITH BRONCHIAL RESECTION, WHEN THE BRONCHI WERE REMOVED, THE FIRING COULD NOT BE PERFORMED AT ALL. IT WAS NOTED THAT THE JAWS WERE COMPLETELY CLOSED AND THE USER WAS ABLE TO PRESS THE GREEN BUTTON. ALSO, THE STAPLE CAME OUT AROUND THE PROXIMAL SIDE OF THE CARTRIDGE'S JAWS. THE SAME HANDLE WAS USED WITH ANOTHER RELOAD TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20190660 ↗
• MalfunctionSep 6, 2024Failure to Cut; Failure to Cut

  ACCORDING TO THE REPORTER, DURING A THORACIC SURGERY, THE SURGEON FIRED THE POWERED STAPLER, THE FIRING WENT SMOOTHLY. WHEN THE STAPLER WAS REMOVED FROM THE CAVITY, THE NURSE THREW THE RELOAD INTO THE TRASH, AND WHEN THE SURGEON CHECKED THE TISSUE, THE STAPLER DID NOT CUT AT ALL, BUT ONLY A TINY LITTLE CUT MARK ON THE TISSUE AT THE BEGINNING, BUT THE STAPLE LINE WAS COMPLETE. ANOTHER RELOAD WAS USED TO CUT THE SAME AREA TO RESOLVE THE ISSUE.

  Patient problems: Tissue Breakdown

  MAUDE report 20161710 ↗

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-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1832-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 30MM MEDIUM/ THICK RELOAD , SIG30AMT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• 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-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