Tri-Staple 2.0 SIGTRS45AXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10884521543621), received between Dec 7, 2017 and Nov 8, 2023 — classified as 1 injury, 37 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A EXPERIMENTAL LAPAROSCOPIC THORACOSCOPIC PULMONARY MALIGNANT TUMOR PARTIAL RESECTION, WHEREIN THE TUMOR WAS SURROUNDED FROM BOTH SIDES AND RESECTED, WHILE RESECTING THE LUNG PARENCHYMA, THE FIRST 45-MILLIMETER (MM) BLACK RELOAD WAS FIRED FROM THE PERIPHERAL SIDE ON ONE SIDE, AND IT FIRED WITH NO PROBLEM. A 45MM SECOND BLACK RELOAD OF THE SAME TYPE WAS USED FOR THE SECOND FIRING ON THE OTHER SIDE OF THE PERIPHERAL SIDE, AND A CRACKING SOUND WAS HEARD. THE HANDLE COULD NOT BE SQUEEZED, AND THE FIRING DID NOT PROCEED AND STOPPED NEAR THE TIP. THE RELOAD WAS RELEASED AND REPLACED WITH A BLACK 60MM RELOAD. THE GREEN BUTTON COULD BE PRESSED, BUT AGAIN, A CRACKING SOUND WAS HEARD, AND THE HANDLE COULD NOT BE SQUEEZED. THE DEVICE DID NOT FIRE. ANOTHER 60MM RELOAD WAS USED AGAIN, BUT THE SAME ISSUE OCCURRED. A NEW HANDLE OF THE SAME TYPE WAS USED WITH A LOADED BLACK 45MM RELOAD; HOWEVER, THE SAME ISSUE OCCURRED. THE SURGEON THEN USED A PURPLE 45MM RELOAD, BUT THE ISSUE DID NOT CHANGE. TO COMPLETE THE CASE, A DIFFERENT DEVICE FROM ANOTHER MANUFACTURER WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097784 ↗
• MalfunctionSep 1, 2023Misfire; Noise, Audible; Misfire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, WHILE ON PULMONARY PARENCHYMA RESECTION, AROUND THE SECOND SQUEEZE, THE KNIFE STOPPED ADVANCING. IT WAS ALSO MENTIONED THAT THERE WAS NO SOUND OF THE GEAR'S POPPING. THE JAWS OF THE DEVICE HAS BEEN FIXATED TO THE TISSUE AND WAS ABLE TO BE REMOVED WITH THE USUAL DEVICE OPERATION OF THE ULTRA HANDLE. ANOTHER RELOAD WAS USED AND THE FIRING COULD BE DONE WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17674690 ↗
• MalfunctionMay 24, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PNEUMOTHORAX PROCEDURE, WHILE RESECTING THE PULMONARY PARENCHYMA, THE APEX OF THE LUNG WAS TEMPORARILY RESECTED. HOWEVER THE SURGEON WAS CONCERNED OF THE FIRST STAPLE LINE, THEREFORE AN ADDITIONAL RESECTION WAS PERFORMED. WHEN THE LAST FIRING WAS FIRED, THE FIRING STOPPED MIDWAY. ADDITIONAL RESECTION FROM THE STAPLE LINE WAS PERFORMED USING A REINFORCEMENT RELOAD AN THE SAME HANDLE TO RESOLVE THE ISSUE. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16993062 ↗
• MalfunctionApr 4, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC LAPAROSCOPY LOBECTOMY, WHEN THE LUNG LOBE WAS TO BE RESECTED, THE STAPLER DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE. ANOTHER RELOAD WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675045 ↗
• MalfunctionJan 31, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC AREA RESECTION UPPER RIGHT LOBE, WHILE AT PULMONARY PARENCHYMA DISLODGEMENT, THE DEVICE WAS CONNECTED TO HANDLE TO ATTEMPT FIRING, BUT FIRING COULD NOT BE PERFORMED. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND UNABLE TO GRIP THE HANDLE. THE RELOAD WAS REPLACED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274694 ↗
• MalfunctionOct 26, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THE PARTIAL LUNG RESECTION PROCEDURE, THE RELOAD WAS LOADED ONTO THE HANDLE. THE NURSE WAS ASSIGNED TO CHECK ITS OPERATION AND THE DEVICE WAS PASSED TO THE PHYSICIAN. THE TISSUE WAS THEN APPROACHED AND TRIED TO FIRE THE STAPLER, BUT THE STAPLER FIRING COULD NOT BE DONE. THE PHYSICIAN WAS ABLE TO PRESS THE GREEN BUTTON BUT UNABLE TO SQUEEZE THE HANDLE. THE NURSE REPORTED THAT THERE WAS NO PROBLEM WHEN THE RELOAD WAS LOADED. 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 15677852 ↗
• MalfunctionAug 10, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, AFTER APPROACHING THE TISSUE, AN ATTEMPT WAS MADE TO PERFORM THE FIRING. THE SURGEON COULD PRESSED THE GREEN BUTTON BUT THE HANDLE COULD NOT BE SQUEEZED. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201009 ↗
• MalfunctionJun 10, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY) LOBECTOMY, WHILE RESECTIONING THE LUNG, THE DEVICE DID NOT FIRE. THE SURGEON WAS UNABLE TO SQUEEZE THE HANDLE DESPITE PRESSING THE GREEN BUTTON. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14657346 ↗
• MalfunctionMay 7, 2022Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY, IN BETWEEN THE LUNG LOBES, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT COULD NOT SQUEEZE THE HANDLE. THE DEVICE DID NOT FIRE. THE JAWS OF THE DEVICE LOCK ON TISSUE AND WAS ABLE TO BE REMOVED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317753 ↗
• MalfunctionMar 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC PARTIAL PULMONARY RESECTION, WHEN RESECTING THE PULMONARY PARENCHYMA, AN ABNORMAL NOISE WAS HEARD FROM THE RELOAD AND ADAPTER. UPON CHECKING, THE PART OF THE RELOAD CONNECTING TO THE ADAPTER BROKE OFF. A COMPETITOR DEVICE WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13663995 ↗
• MalfunctionFeb 18, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PARTIAL RESECTION OF LUNG, THE DEVICE WAS ABLE TO CLAMP THE TISSUE, BUT COULD NOT FIRE. A NEW RELOAD WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559798 ↗
• MalfunctionDec 7, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING PANCREAS RESECTION OR SMALL INTESTINE RESECTION IN AN OPEN ABDOMINAL PANCREATODUODENECTOMY SURGERY, AN ATTEMPT WAS MADE TO PERFORM FIRING, BUT FIRING COULD NOT BE PERFORMED ON TWO DEVICES. THE SURGEON WAS ABLE TO PRESSED THE GREEN BUTTON, BUT CLOUD NOT SQUEEZED THE HANDLE. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12957680 ↗
• MalfunctionNov 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE STAPLER AND RELOAD WERE LOADED NORMALLY. THE NURSE THEN HANDED THE DEVICE TO THE SURGEON AND THE SURGEON PLACED IT INTO THE THORACIC CAVITY, AND THE RELOAD THEN FELL OFF INTO THE CAVITY. THE HANDLE WAS REMOVED AND THE RELOAD WAS RETRIEVED. ANOTHER HANDLE AND RELOAD WERE OPENED AND USED TO COMPLETE LAPAROSCOPIC RIGHT THORACOSCOPIC WEDGE RESECTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775682 ↗
• InjuryOct 20, 2021Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, AT THE SECOND FIRING ON THE ANTRUM DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THERE WAS A POOR STAPLE FORMATION. IT WAS ALSO NOTED THAT THE SURGEON COULD NOT COMPLETE MAJORITY OF THE FIRING AFTER STARTING AND GOT TOO MUCH TISSUE SIGNAL. THE SURGEON WAITED MINUTES BETWEEN ATTEMPTS FOR PERFUSION, REPRESSED AND DID NOT FIRE ANY MORE. A NEW RELOAD WAS USED ON THE SAME POWER HANDLE, ADAPTER AND SHELL. THEN, THE SURGEON HAD TO STAPLE INSIDE THE ORIGINAL CUT LINE AND MAKE THE SLEEVE TIGHTER/SMALLER TO COMPLETE THE CASE. THE SLEEVE TOOK 2 HOURS INSTEAD OF 40 MINUTES.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12666896 ↗
• MalfunctionOct 20, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, NOT ALL CLAMPS WERE TRIGGERED WHEN THE RELOAD WAS FIRED. SURGEON REPLACED THE RELOAD TO RESOLVE THE ISSUE. NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT THE DEVICE WAS FOUND TO BE PARTIALLY FIRED. EVALUATION OF THE DEVICE¿S CONDITION REVEALED THAT IT HAD BEEN APPLIED ON TISSUE BEYOND THE INDICATED RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665953 ↗
• MalfunctionJul 25, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING VIDEO-ASSISTED THORACOSCOPIC BULLA RESECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND COULD NOT SQUEEZE THE HANDLE. HENCE, THE STAPLER DID NOT FIRE WHEN RESECTING THE LUNG PARENCHYMA. BOTH THE HANDLE AND RELOAD WERE REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223021 ↗
• MalfunctionFeb 4, 2021Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, THE SURGEON WAS NOT ABLE TO PRESS THE GREEN BUTTON AND WAS NOT ABLE TO SQUEEZE THE HANDLE. THE DEVICE DID NOT FIRE. A NEW HANDLE WAS USED TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT THE RELOAD WAS NOT ABLE TO BE USED WITH THE NEW HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282253 ↗
• MalfunctionOct 20, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON A THORACIC WEDGE SEGMENTAL RESECTION, DURING THE FIRST FIRING, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON BUT WAS UNABLE TO SQUEEZE THE HANDLE. THE SURGEON TRIED TO FIRE AGAIN BUT WAS STILL UNABLE TO FIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10704033 ↗
• MalfunctionSep 23, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THORACOSCOPIC WEDGE SEGMENTAL RESECTION PROCEDURE, ON THE SECOND FIRING, THE DEVICE JAWS WERE ABLE TO OPENED AND CLOSED, BUT AFTER CLAMPING THE TISSUE AND PRESSING THE GREEN BUTTON, THE HANDLE COULD NOT BE SQUEEZE AND THE DEVICE COULD NOT BE FIRE. THE PROCEDURE WAS COMPLETED WITH A NEW RELOAD. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10571976 ↗
• MalfunctionSep 8, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING SLEEVE GASTRECTOMY, WHEN THEY OPENED THE RELOAD, THE BLACK TIP WAS BROKEN. SURGEON USED ANOTHER RELOAD TO RESOLVE THE ISSUE. THE DEVICE WAS NOT USED ON THE PATIENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10505063 ↗
• MalfunctionAug 21, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING THORACO/ LOBECTOMY, WHEN THE REINFORCEMENT CARTRIDGE WAS USED ON THE LUNG PARENCHYMA, IT WAS SO HARD THAT THE FIRING WAS UNABLE TO BE PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10438088 ↗
• MalfunctionApr 1, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, AS THE RELOAD WAS APPLIED TO THE STOMACH DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY, IT WAS STATED THAT THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE, HOWEVER, THE RELOAD WOULD NOT CLOSE OVER THE TISSUE. ANOTHER RELOAD WAS OPENED AND USED TO COMPLETE THE CASE. THERE WAS NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911118 ↗
• MalfunctionMar 31, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A WEDGE SEGMENTAL RESECTION PROCEDURE, AT FIRST FIRING, WHEN THE POWER HANDLE AND THE REINFORCEMENT WERE CONNECTED, THE SCREEN DISPLAY BECAME STRANGE WHEREIN THE ZONE DISPLAY COULD NOT BE CHECKED ON THE INCONGRUOUS DISPLAY THAT IS DIVIDED IN FOUR. THE FIRING WAS DONE WITHOUT ISSUE. HOWEVER, ON THE SECOND FIRING, THE SAME ISSUE OCCURRED WITH THE DISPLAY WHEN THE TISSUE WAS CLAMPED. AND THE DEVICE DID NOT FIRE. RE-SETTING WAS PERFORMED FROM THE ADAPTER BUT THE ISSUE PERSIST. A MANUAL HANDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9908572 ↗
• MalfunctionMar 2, 2020Difficult to Open or Close; Difficult to Open or Close

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, WHEN THE DEVICE WAS APPLIED TO THE STOMACH THE JAWS WOULD NOT CLOSE. A NEW RELOAD WAS OPENED AND WORKED WELL WITH NO ISSUE ON THE SAME HANDLE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9774245 ↗
• MalfunctionJan 9, 2020Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER AT FIFTH FIRING DURING A LUNG PARENCHYMA RESECTION ON A THORACOSCOPIC VIDEO ASSISTED SURGERY, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE; HOWEVER, THE ANCHORING SUTURE ON THE CARTRIDGE SIDE WAS DISENGAGED. AS A RESULT, THE LUNG PARENCHYMA AND THE CARTRIDGE COULD NOT BE SEPARATED BUT THE SHEET CAME OFF WITHOUT ANY PROBLEMS. A FORCEPS AND SCISSORS WERE USED TO CUT THE TISSUE BY FORCE TO BE REMOVED FROM THE DEVICE. NO TISSUE DAMAGE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569337 ↗

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-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-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• 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-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-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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• 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-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