Tri-Staple 2.0 SIG30AVRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10884521543676), received between Jan 29, 2018 and Nov 11, 2025 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (15 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC SURGERY (VATS) LOBECTOMY, THERE WAS STAPLE LINE BLEEDING. THE SURGEON USED A CLIP APPLIER TO STOP RANDOM BLEEDS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23521839 ↗
• MalfunctionJul 22, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PULMONARY BLOOD VESSEL RESECTION, THE USER WAS UNABLE TO SQUEEZE THE HANDLE AND FIRE THE DEVICE. A HANDLE AND RELOAD OF THE SAME STANDARD WERE USED TO RESOLVE THE ISSUE, AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562489 ↗
• MalfunctionApr 21, 2025Misfire; Misfire

  ACCORDING TO THE REPORTER, THERE WAS A MISFIRING OF THE STAPLER, AND A SECOND STAPLER WAS OPENED TO RESECT THE APPENDIX STUMP.

  Patient problems: Insufficient Information

  MAUDE report 21875139 ↗
• InjuryOct 2, 2024Failure to Form Staple; Mechanics Altered; Failure to Form Staple; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS), AFTER THE DEVICE WAS FIRED ON THE PULM ONARY ARTERY, ONE SIDE OF THE PULMONARY ARTERY DID NOT SEAL. THE DEVICE WAS ABLE FULLY CUT THE TISSUE HOWEVER ONLY 50% OF THE STAPLES WERE ABLE TO DEPLOY ON ONE SIDE. THE PATIENT LOST APPROXIMATELY TWO LITERS OF BLOOD AND HAD SIGNIFICANT DROP IN THE BLOOD PRESSURE DUE THE ISSUE. A BLOOD TRANSFUSION OF 4 UNITS OF BLOOD WAS PERFORMED. AN ADDITIONAL DEVICE WAS REQUIRED TO CONTROL THE BLEEDING. THE PROCEDURE HAD TO BE CONVERTED TO OPEN IN ORDER TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED BY 1-1.5 HOURS DUE TO THE CONVERSION. THE PATIENT WAS MOVED TO THE ICU FOR OBSERVATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); Low Blood Pressure/ Hypotension; Tissue Breakdown

  MAUDE report 20351590 ↗
• MalfunctionJul 25, 2024Retraction Problem; Misfire; Retraction Problem; Misfire

  ACCORDING TO THE REPORTER, DURING NEPHRECTOMY, WHEN RESECTING THE URETER, THE FIRING STOPPED HALFWAY THROUGH THE PROCEDURE. THE HANDLE COULD NOT BE SQUEEZED AND THE KNIFE BLADE COULD NOT BE RETRACTED. 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 19827818 ↗
• MalfunctionJul 10, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY, AT THE TIME OF VASCULAR TREATMENT, THE FIRING COULD NOT BE DONE AT ALL. A NEW RELOAD WAS USED WITH THE SAME MANUAL HANDLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710334 ↗
• MalfunctionJan 5, 2024Entrapment of Device; Failure to Fire; Entrapment of Device; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, WHILE ON SUTURING, RESECTION, FIRING, THE DEVICE WAS CLAMPED AND WAS EVEN ABLE TO PRESS THE GREEN BUTTON, BUT THE HANDLE COULD NOT BE SQUEEZED AND FIRING COULD NOT BE PERFORMED. IT WAS MENTIONED THAT THE JAW OF THE DEVICE WAS FIXATED TO TISSUE AND WAS ABLE TO BE REMOVED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18460934 ↗
• MalfunctionJun 29, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A KIDNEY TRANSPLANT PROCEDURE, ON THE SECOND RELOAD, THE USER COULD NOT PRESS THE GREEN BUTTON; HENCE, FIRING COULD NOT BE DONE. TO RESOLVE THE ISSUE, A NEW RELOAD WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17232620 ↗
• MalfunctionMay 2, 2023Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, DURING A LUNG LOBECTOMY, WHEN PERFORMING THE PULMONARY ARTERY TREATMENT, AFTER PRESSING THE GREEN BUTTON; THE KNIFE DID NOT ADVANCED AND FIRING COULD NOT BE DONE. THERE WAS A POSSIBILITY OF PRE-FIRE. A NEW CARTRIDGE WAS USED TO RESOLVE THE ISSUE.

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

  MAUDE report 16854858 ↗
• MalfunctionJan 18, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VATS (VIDEO-ASSISTED THORACOSCOPIC SURGERY), WHILE RESECTING THE PULMONARY VEIN, THE GREEN BUTTON WAS PRESSED AND THE HANDLE WAS SQUEEZED, BUT THE DEVICE DID NOT FIRE. A NEW RELOAD OF THE SAME KIND WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16195082 ↗
• MalfunctionFeb 15, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC SURGERY, THE CARTRIDGE DID NOT FIRE AFTER CONNECTING TO THE HANDLE AND ADAPTER. A NEW RELOAD AND THE SAME HANDLE, SHELL AND ADAPTER WERE USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538825 ↗
• MalfunctionNov 23, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPIC LOBECTOMY OF THE LUNG, AFTER ATTACHING THE CARTRIDGE TO THE ADAPTER USING THE POWER HANDLE AND REMOVING THE YELLOW TAB FROM THE CARTRIDGE IN ORDER TO CHECK THE OPENING AND CLOSING OF THE JAWS, THE USER NOTICED THAT THE PROTRUSION PART OF THE YELLOW TAB WAS DAMAGED AND BROKE OFF. IT WAS NOTED NO DAMAGE SITE WAS FOUND. IT WAS CONFIRMED THAT THE FOREIGN OBJECT HAD NOT FALLEN INTO THE SURGICAL FIELD, AND THE OPERATION WAS CONTINUED AS USUAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12865462 ↗
• MalfunctionOct 21, 2021Break; Component Missing; Detachment of Device or Device Component; Break; Component Missing; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC THORACOSCOPY PULMONARY RESECTION, AFTER FIRING THE TISSUE, IT WAS OBSERVED THAT THE FRAGMENTS FROM THE YELLOW TAB CAME OFF IN THE SURGICAL FIELD. AMONG THE PRODUCTS USED IN THE SAME CASE, FOUR YELLOW TABS WERE MISSING, TWO OF THEM WERE REMOVED FROM THE SURGICAL FIELD. FOR THE FIRST FIRING, THE NURSE CHECKED THE OPENING AND CLOSING OF THE JAWS WHILE THE YELLOW TAB WAS STILL ON, AFTER THE SECOND FIRING, THE YELLOW TAB WAS REMOVED AS PER THE INSTRUCTIONS FOR USE, AFTER BEING POINTED OUT BY THE CIRCULATING NURSE. THE OPENING AND CLOSING CHECK FOR THE JAWS WAS PERFORMED, BUT AS A RESULT, THE YELLOW TABS OF THE FOUR CARTRIDGES WERE MISSING. THE FRAGMENTS FROM THE YELLOW TAB THAT HAD FALLEN INTO THE SURGICAL FIELD WAS COLLECTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12676969 ↗
• InjuryJul 8, 2021Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, ON A HAND ASSISTED LAPAROSCOPIC PANCREATECTOMY, WHILE LIGATING THE ARTERY, THE STAPLE LINE WAS INCOMPLETE CENTRALLY. CLIPS AND SUTURE WERE USED TO FIX THE ISSUE. THE OTHER RELOADS WORKED NORMALLY WITH THE HANDLE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12139020 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBAL RESECTION, ON LOBUS RESECTION, AFTER FIRING THE RELOAD ON THE TISSUE, THERE WAS A MINIMAL BLEEDING ALONGSIDE THE STAPLE LINE, THAT STOPPED AFTER A WHILE OF WAITING SPONTANEOUSLY. THERE WAS A LITTLE PRESSURE APPLIED ON THE SUTURE AND ONE SINGLE STITCH TO STOP A VERY SLIGHT BLEEDING ON THE STAPLE LINE AFTER FIRING OF THE INSTRUMENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11300577 ↗
• MalfunctionDec 28, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACOSCOPY ESOPHAGECTOMY, WHEN THE PARADOXICAL VEIN WAS CLOSED, AFTER THE STAPLING WAS COMPLETED, THE RELOAD COULD NOT BE RETURNED. IT WAS RELEASED USING MANUAL ADAPTER TOOL. AFTER THE OPERATION, ANOTHER SHELL WAS USED AND STAPLING WAS PERFORMED WITH ANOTHER RELOAD, IT WORKED WITHOUT PROBLEMS. SINCE IT WAS A BLOOD VESSEL, IT WAS NOT PARTICULARLY THICK, AND THERE WAS NO THICKENING OR CALCIFICATION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077071 ↗
• MalfunctionMar 18, 2020Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACO-LOBECTOMY PROCEDURE, THE SURGEON TRIED TO FIRE THE DEVICE, BUT IT COULDN'T FIRE. THE DEVICE WAS NOT USED IN THE PATIENT. A CARTRIDGE WAS REPLACED THEN IT WORKED, THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9847388 ↗
• MalfunctionMar 12, 2020Entrapment of Device; Entrapment of Device

  ACCORDING TO THE REPORTER DURING A THORACO LOBECTOMY WHEN THE TWO CARTRIDGES WERE USED, THE TISSUE WAS STUCK TO THE CARTRIDGE AND DID NOT COME OFF. AS IT WAS USED ON THE SPECIMEN SIDE, NO BIG ISSUE AROSE. THE DEVICE WAS REMOVED FROM THE TISSUE BY FORCE BUT NO TISSUE DAMAGE WAS CAUSED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9823905 ↗
• MalfunctionFeb 3, 2020Failure to Fire; Expulsion; Failure to Fire; Expulsion

  ACCORDING TO THE REPORTER, ON A THORACIC LOBECTOMY, DURING THE FIRST FIRING, WHILE CLAMPING THE BLOOD VESSEL AND TRYING TO FIRE, THE HANDLE COULD NOT BE SQUEEZED. ANOTHER RELOAD WAS USED TO COMPLETE THE CASE. WHEN THE RELOAD WAS CHECKED, IT WAS FOUND THAT THE STAPLE WAS PUSHED UP FROM THE PROXIMAL PART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9659783 ↗
• MalfunctionNov 7, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER DURING A NEPHRECTOMY, WHEN THE SURGEON USED THE REPORTED PRODUCT ON THE RENAL VEIN. THEY CONNECTED THE CARTRIDGE TO THE HANDLE AND CHECKED THE JAWS OPENING/CLOSING. THE SURGEON APPROACHED TO THE RENAL VEIN AND TRIED TO FIRE THE DEVICE, BUT HE/SHE COULD NOT SQUEEZE THE HANDLE. THEY CONNECTED NEW CARTRIDGE TO THE SAME HANDLE ,AND THE SURGEON COULD FIRE THE DEVICE WITH NO PROBLEM. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290234 ↗
• MalfunctionOct 24, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, AT THE FIRST FIRING DURING A LAPAROSCOPIC NEPHRECTOMY, THE BLOOD VESSEL WAS CLAMPED BUT FIRING COULD NOT BE PERFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9233105 ↗
• MalfunctionSep 24, 2019Entrapment of Device; Misfire; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER, DURING A THORACO/ESOPHAGUS PROCEDURE, WHEN CLAMPING THE AZYGOS VENOUS ARCH, THE GREEN BUTTON REMAINED POOPED OUT AND THE HANDLE WAS NOT PUSHED OUT ETHER. WHEN OPENING AND CLOSING THE HANDLE FOR SEVERAL TIMES, THE HANDLE WAS PUSHED OUT AND IT BECAME POSSIBLE TO FIRE. EVEN THOUGH THE DEVICE WAS FIRED, IT COULD NOT FIRE FOR MORE THAN 1 SCALE. CUTTING WAS PERFORMED AFTER PERFORMING LIGATION AND CLIPPING ON THE TWO SIDES. SURGEON USED ANOTHER HANDLE AND THE PROBLEM WAS RESOLVED. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MIN. THE TISSUE WAS FREED FROM THE DEVICE BY PULLING BACK THE BLACK KNOB. NO PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 9111337 ↗
• MalfunctionSep 3, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, ON THE FIRST FIRING DURING A LAPAROSCOPIC LIVING DONOR NEPHRECTOMY, THE SURGEON TURNED THE DEVICE TO FIRE MODE AND SQUEEZED THE HANDLE BUT THE DEVICE WAS NOT ABLE TO FIRE. THE HANDLE AND THE RELOAD WERE REPLACED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8958508 ↗
• MalfunctionAug 12, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING HEPATECTOMY, THE FIRING OPERATION OF THE DEVICE WAS PERFORMED, BUT THE IT DID NOT WORK. WHEN OPENING THE RELOAD'S JAWS, USED RELOAD WAS DISPLAYED ON THE DEVICE DISPLAY. A NEW RELOAD WAS USED. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8882021 ↗
• MalfunctionJul 21, 2019Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LOBECTOMY PROCEDURE, THE SURGEON TRIED TO FIRE, BUT THE HANDLE COULD NOT BE SQUEEZED AND THE DEVICE COULD NOT BE FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8810125 ↗

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-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1826-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• 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-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• Z-1825-2019 · May 17, 2019 · Open, Classified
  EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT
• Z-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• 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-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