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Tri-Staple 2.0 SIG30CTAVMRecalls & reported problems

Covidien LP · Curved Tip Intelligent Reload and Introducer · Class 2 · Implant

Quick summary

This Covidien Tri-Staple 2.0 reload is a curved staple cartridge used in surgery. The 235 reports mostly describe staples or reloads that did not fire or form properly, with some reports of bleeding from the staple line and tissue breakdown. The reports include 68 injuries and 3 deaths, and some describe surgeons adding sutures or replacing the reload to finish the procedure. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
236
Deaths reported
3
Injuries reported
68
Recalls naming it
0

Summary

The FDA's MAUDE database contains 236 adverse event reports that list this exact device (DI 10884521543744), received between Jun 7, 2017 and Sep 22, 2026 — classified as 3 deaths, 68 injuries, 165 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (65 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 3 reportsJan 2024: 2 reportsFeb 2024: 4 reportsMar 2024: 2 reportsApr 2024: 2 reportsMay 2024: 3 reportsJun 2024: 3 reportsJul 2024: 3 reportsAug 2024: 2 reportsSep 2024: 6 reportsOct 2024: 2 reportsNov 2024: 3 reportsDec 2024: 2 reportsJan 2025: 10 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 4 reportsJul 2025: 2 reportsAug 2025: 1 reportsSep 2025: 0 reportsOct 2025: 2 reportsNov 2025: 5 reportsDec 2025: 0 reportsJan 2026: 5 reportsFeb 2026: 2 reportsMar 2026: 2 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports20242025202610
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem65
  • Failure to Fire65
  • Failure to Form Staple41
  • Misfire25
  • Failure to Cut15
  • Detachment of Device or Device Component13
  • Entrapment of Device13
  • Difficult to Open or Close12

Patient problems

  • No Clinical Signs, Symptoms or Conditions86
  • Hemorrhage/Blood Loss/Bleeding46
  • Tissue Breakdown31
  • No Consequences Or Impact To Patient27
  • No Known Impact Or Consequence To Patient22
  • Unspecified Tissue Injury22
  • No Code Available21
  • Insufficient Information8

Recent adverse event reports

The 25 most recent of 236 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 22, 2026Failure to Form Staple

    It was reported that during a laparoscopic VATS (video-assisted thoracoscopic surgery) procedure, the handle and reload were fired, and the staples appeared to deploy but did not form correctly.

    Patient problems: Tissue Breakdown

    MAUDE report 50849987 ↗
  • MalfunctionAug 24, 2026Failure to Cut

    Patient problems: Tissue Breakdown

    MAUDE report 50421486 ↗
  • MalfunctionApr 24, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT UPPER LOBECTOMY PROCEDURE, IN PULMONARY VEIN, THE PATIENT CONTINUED TO BLEED AFTER STAPLES WERE FIRED. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

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

    MAUDE report 24982742 ↗
  • MalfunctionApr 24, 2026Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RIGHT UPPER LOBECTOMY PROCEDURE, IN PULMONARY VEIN, THE PATIENT CONTINUED TO BLEED AFTER STAPLES WERE FIRED. SUTURING WAS PERFORMED AS STAPLE LINE REINFORCEMENT.

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

    MAUDE report 24982494 ↗
  • MalfunctionMar 30, 2026Failure to Form Staple

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC THORACOTOMY, AFTER FIRING THE RELOAD WITH A MANUAL HANDLE, THE STAPLES DID NOT ADEQUATELY CLOSE, RESULTING IN BLOOD LEAKING FROM THE STAPLE LINE. THIS LED TO AN EXTENSION OF SURGICAL TIME OF LESS THAN 30 MINUTES, THOUGH THE DELAY WAS NOT PROLONGED. THE SURGICAL TEAM REPLACED THE RELOAD, RESECTED, AND RE-STAPLED THE AFFECTED AREA TO ADDRESS THE STAPLE FORMATION ISSUE AND STAPLE LINE BLEEDING.

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

    MAUDE report 24713179 ↗
  • MalfunctionMar 30, 2026Failure to Form Staple

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC THORACOTOMY, AFTER FIRING THE RELOAD WITH A MANUAL HANDLE, THE STAPLES DID NOT ADEQUATELY CLOSE, RESULTING IN BLOOD LEAKING FROM THE STAPLE LINE. THIS LED TO AN EXTENSION OF SURGICAL TIME OF LESS THAN 30 MINUTES, THOUGH THE DELAY WAS NOT PROLONGED. THE SURGICAL TEAM REPLACED THE RELOAD, RESECTED, AND RE-STAPLED THE AFFECTED AREA TO ADDRESS THE STAPLE FORMATION ISSUE AND STAPLE LINE BLEEDING.

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

    MAUDE report 24713048 ↗
  • MalfunctionFeb 11, 2026Failure to Fire

    IT WAS REPORTED THAT DURING THE VIDEO ASSISTED THORACOSCOPIC LOBECTOMY, THE RELOAD WAS LOADED BY A SCRUB NURSE, AND IT WOULD NOT FIRE. THE SURGEON WAS ABLE TO PRESS THE GREEN SAFETY BUTTON BUT WAS NOT ABLE TO SQUEEZE THE HANDLE. IT WAS SUSPECTED THAT THE RELOAD MAY HAVE BEEN PARTIALLY FIRED PRIOR TO LOADING, WHICH PREVENTED IT FROM FUNCTIONING WHEN RELOADED ONTO THE SAME MANUAL HANDLE.  THE ISSUE WAS RESOLVED BY LOADING A NEW RELOAD ONTO A NEW GUN, WHICH THEN FIRED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24317663 ↗
  • MalfunctionFeb 2, 2026Retraction Problem; Firing Problem

    ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC SURGERY (VATS) S6 (SEGMENT 6) AREA RESECTION, AT THE TIME OF ARTERY 6 (A6) RESECTION, ALTHOUGH IT WAS DIFFICULT TO FIRE, FIRING COULD BE DONE TO THE END. AFTER COMPLETING THE FIRING, RETRACTING THE KNIFE PROVED EXTREMELY DIFFICULT. IT WAS NOTED THAT THE BENDING WAS 4 STEPS TO THE LEFT, AND IT ONLY RETURNED TO THE FIRST STEP DURING RELEASE. DUE TO IT BEING IMMEDIATELY AFTER FIRING INTO A6, IT WAS RELEASED CAREFULLY, AND IT TOOK ABOUT 10 MINUTES TO COMPLETE THE RELEASE. TREATMENT INTERVENTION WAS NOT PERFORMED/NOT NECESSARY. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24237550 ↗
  • MalfunctionJan 20, 2026Unintended System Motion

    ACCORDING TO THE REPORTER, DURING A ROBOTIC-ASSISTED THORACOSCOPIC SURGERY (RATS) LOBECTOMY, ON THE PULMONARY BLOOD VESSEL, THE FIRING WAS ABLE TO BE PERFORMED WITHOUT ANY PROBLEMS, BUT THERE WAS A SIGNIFICANT TWITCHING DURING FIRING, SO IT WAS REGISTERED. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24122606 ↗
  • MalfunctionJan 20, 2026Failure to Form Staple; Failure to Cut

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN USING THE RELOAD ON THE UPPER LOBE PULMONARY ARTERY, THE STAPLES FIRED BUT THE DEVICE DID NOT CUT THE TISSUE. THE PROXIMAL STAPLE LINE DID NOT SEAL. TO RESOLVE THE ISSUE, SEVERAL BLUE CLIPS FROM A DIFFERENT MANUFACTURER WERE APPLIED TO REINFORCE, ARTERY DIVIDED USING DEVICE.

    Patient problems: Tissue Breakdown

    MAUDE report 24118427 ↗
  • MalfunctionJan 15, 2026Failure to Form Staple

    ACCORDING TO THE REPORTER, DURING THE SEGMENTECTOMY PROCEDURE TYPICAL OF THE CULMEN OR UPPER LOBE OF THE LEFT UPPER LOBE USING THE SINGLE-PORT TECHNIQUE WITH A WOUND PROTECTION SYSTEM FROM ANOTHER MANUFACTURER, THE SURGEON DETECTED AN ANOMALOUS CONFIGURATION OF THE STAPLES OF THE THREE VASCULAR CARTRIDGES. TWO ON THE ARTERIAL BRANCH AND ONE ON THE VENOUS BRANCH. IT WAS NOTED THAT A POWERED HANDLE WAS USED THEN A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE.

    Patient problems: Tissue Breakdown

    MAUDE report 24083042 ↗
  • MalfunctionJan 15, 2026Failure to Form Staple

    ACCORDING TO THE REPORTER, DURING THE SEGMENTECTOMY PROCEDURE TYPICAL OF THE CULMEN OR UPPER LOBE OF THE LEFT UPPER LOBE USING THE SINGLE-PORT TECHNIQUE WITH A WOUND PROTECTION SYSTEM FROM ANOTHER MANUFACTURER, THE SURGEON DETECTED AN ANOMALOUS CONFIGURATION OF THE STAPLES OF THE THREE VASCULAR CARTRIDGES. TWO ON THE ARTERIAL BRANCH AND ONE ON THE VENOUS BRANCH. IT WAS NOTED THAT A POWERED HANDLE WAS USED THEN A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE.

    Patient problems: Tissue Breakdown

    MAUDE report 24083024 ↗
  • MalfunctionJan 15, 2026Failure to Form Staple

    ACCORDING TO THE REPORTER, DURING THE SEGMENTECTOMY PROCEDURE TYPICAL OF THE CULMEN OR UPPER LOBE OF THE LEFT UPPER LOBE USING THE SINGLE-PORT TECHNIQUE WITH A WOUND PROTECTION SYSTEM FROM ANOTHER MANUFACTURER, THE SURGEON DETECTED AN ANOMALOUS CONFIGURATION OF THE STAPLES OF THE THREE VASCULAR CARTRIDGES. TWO ON THE ARTERIAL BRANCH AND ONE ON THE VENOUS BRANCH. IT WAS NOTED THAT A POWERED HANDLE WAS USED THEN A MANUAL STAPLER WAS USED TO RESOLVE THE ISSUE.

    Patient problems: Tissue Breakdown

    MAUDE report 24082990 ↗
  • MalfunctionNov 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT DURING THE LOBECTOMY, EXCESSIVE BLEEDING OCCURRED FROM STAPLE LINES AFTER FIRING OVER THE PULMONARY VEIN AND PULMONARY ARTERY USING THE. STAPLE LINE BLEEDING WAS NOTED ON ALL FOUR FIRINGS. BLEEDING WAS RESOLVED WITH THE APPLICATION OF CLIPS AND PRESSURE.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 23665392 ↗
  • MalfunctionNov 26, 2025Mechanics Altered; Mechanics Altered

    IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, THE STAPLES DID NOT DEPLOY, BUT THE DEVICE CUTS THE TISSUE.

    Patient problems: Tissue Breakdown

    MAUDE report 23660124 ↗
  • MalfunctionNov 16, 2025Failure to Cut; Failure to Cut

    IT WAS REPORTED THAT DURING A RIGHT UPPER LOBECTOMY, WHEN THE SURGEON ATTEMPTED TO STAPLE A SMALL ACCESSORY VESSEL; THE STAPLES DEPLOYED BUT THE KNIFE BLADE DID NOT CUT BETWEEN THE STAPLE LINE. THE SURGEON USED LAPAROSCOPIC SCISSORS TO CUT BETWEEN THE STAPLE LINE AS A PROCEDURAL WORKAROUND. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23565861 ↗
  • InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, THE PASSAGE AROUND THE BASAL SEGMENTAL PULMONARY ARTERY HAD GOOD SPACE. THE PULMONARY ARTERY APPEARED NORMAL SIZE, WITH NORMAL TISSUE QUALITY. THE 30 MM CURVED TIP RELOAD PASSED WITHOUT RESISTANCE OR TENSION. ON FIRING THE STAPLER, THERE WAS ABSOLUTELY NO RESISTANCE. AFTER OPENING THE STAPLER, THERE WAS BLEEDING ON THE PULMONARY ARTERY (PATIENT AND SPECIMEN SIDE) FROM THE STUMP ENDS AND AROUND THE STAPLE LINES. PRESSURE WAS APPLIED WITH A SWAB ON A STICK FOR 10 MINUTES, AND THE BLEEDING WAS STOPPED. THE SECOND BRANCH OF THE PULMONARY ARTERY (SEGMENT 6 ARTERY) WAS DISSECTED AND AGAIN HAD SMOOTH PASSAGES, WITH NO RESISTANCE AND NO BRUISING ON THE ARTERY. A FURTHER 30 CURVED TIP TAN RELOAD WAS USED. THE SAME FEELING OCCURRED ON FIRING, AND AGAIN BLEEDING OCCURRED. THE BLEEDING FROM THIS SLIGHTLY SMALLER PA BRANCH WAS MORE THAN FROM THE LARGER BRANCH. A HEMOSTATIC PRODUCT WAS APPLIED, FOLLOWED BY CONTINUOUS PRESSURE WITH A SWAB ON A STICK AGAIN. THE BLEEDING STOPPED. A HEMOSTATIC PATCH WAS THEN APPLIED OVER THE STUMPS FOR SECURITY. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES TO PRESS THE PULMONARY ARTERY TO ST

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 23452139 ↗
  • InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACOSCOPIC LOBECTOMY, THE PASSAGE AROUND THE BASAL SEGMENTAL PULMONARY ARTERY HAD GOOD SPACE. THE PULMONARY ARTERY APPEARED NORMAL SIZE, WITH NORMAL TISSUE QUALITY. THE 30 MM CURVED TIP RELOAD PASSED WITHOUT RESISTANCE OR TENSION. ON FIRING THE STAPLER, THERE WAS ABSOLUTELY NO RESISTANCE. AFTER OPENING THE STAPLER, THERE WAS BLEEDING ON THE PULMONARY ARTERY (PATIENT AND SPECIMEN SIDE) FROM THE STUMP ENDS AND AROUND THE STAPLE LINES. PRESSURE WAS APPLIED WITH A SWAB ON A STICK FOR 10 MINUTES, AND THE BLEEDING WAS STOPPED. THE SECOND BRANCH OF THE PULMONARY ARTERY (SEGMENT 6 ARTERY) WAS DISSECTED AND AGAIN HAD SMOOTH PASSAGES, WITH NO RESISTANCE AND NO BRUISING ON THE ARTERY. A FURTHER 30 CURVED TIP TAN RELOAD WAS USED. THE SAME FEELING OCCURRED ON FIRING, AND AGAIN BLEEDING OCCURRED. THE BLEEDING FROM THIS SLIGHTLY SMALLER PA BRANCH WAS MORE THAN FROM THE LARGER BRANCH. A HEMOSTATIC PRODUCT WAS APPLIED, FOLLOWED BY CONTINUOUS PRESSURE WITH A SWAB ON A STICK AGAIN. THE BLEEDING STOPPED. A HEMOSTATIC PATCH WAS THEN APPLIED OVER THE STUMPS FOR SECURITY. THE SURGICAL TIME WAS EXTENDED BY 30 MINUTES TO PRESS THE PULMONARY ARTERY TO ST

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 23451667 ↗
  • InjuryOct 22, 2025Unintended System Motion; Adverse Event Without Identified Device or Use Problem; Unintended System Motion; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING AN OPEN LOWER LOBECTOMY AFTER CHEMO-IMMUNOTHERAPY, AFTER CORRECT PLACEMENT, CLOSURE, AND FIRING, THE POWERED STAPLER WAS INSERTED IN AN ANGLED POSITION, AND IT AUTONOMOUSLY ADDED FURTHER ANGULATION DURING FIRING, EVEN WHEN THE HANDLE WAS HELD STILL. IT CAUSED TRACTION ON THE UNDERLYING TISSUES. THIS RESULTED IN 700 CUBIC CENTIMETERS (CC) OF BLOOD LOSS FROM THE PULMONARY ARTERY AND THE TRANSFUSION OF 2 PACKED CELLS. THE SURGEON USED A DIFFERENT STAPLER FROM ANOTHER MANUFACTURER TO RESOLVE THE ISSUE.

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

    MAUDE report 23363359 ↗
  • MalfunctionOct 22, 2025Unintended System Motion; Adverse Event Without Identified Device or Use Problem; Unintended System Motion; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE REPORTER, DURING AN OPEN PANCOAST RESECTION INCLUDING REMOVAL OF THREE RIBS AND THREE VERTEBRAE, AFTER CORRECT PLACEMENT, CLOSURE, AND FIRING, THE POWERED STAPLER WAS INSERTED IN AN ANGLED POSITION, AND IT AUTONOMOUSLY ADDED FURTHER ANGULATION DURING FIRING EVEN WHEN THE HANDLE WAS HELD STILL. IT CAUSED TRACTION ON THE UNDERLYING TISSUES. THIS RESULTED IN BLEEDING FROM THE PULMONARY ARTERY. THE SURGEON USED A DIFFERENT STAPLER FROM ANOTHER MANUFACTURER TO RESOLVE THE ISSUE.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 23357718 ↗
  • InjuryAug 11, 2025Failure to Form Staple; Failure to Form Staple

    IT WAS REPORTED THAT DURING A RIGHT UPPER LOBECTOMY, THE RELOAD WAS LOADED AND FIRED WITH NO ISSUES; HOWEVER, WHEN THE STAPLER WAS OPENED, THE VEIN BEGAN TO BLEED RAPIDLY. THE PROXIMAL END OF THE VEIN, CLOSEST TO THE APEX OF THE STAPLER, APPEARED CUT BUT NOT STAPLED, WITH APPROXIMATELY 2MM. THE PATIENT LOST APPROXIMATELY 1.3 LITERS OF BLOOD DURING SURGERY. A THORACOTOMY WAS REQUIRED TO ACCESS AND SUTURE THE BLEEDING VEIN, AND SURGICAL TIME WAS EXTENDED BY APPROXIMATELY HALF AN HOUR. THE PATIENT WAS REPORTED TO BE STABLE AT THE END OF THE PROCEDURE, AND TUMOR REMOVAL WAS SUCCESSFUL.

    Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Perforation of Vessels; Tissue Breakdown

    MAUDE report 22778219 ↗
  • MalfunctionJul 3, 2025Misfire; Misfire

    ACCORDING TO THE REPORTER, DURING A LUNG PROCEDURE INVOLVING THE USE OF A VASCULAR STAPLER, THE RELOAD FAILED TO PROPERLY SEAL AROUND THE LUNG TISSUE. AS A RESULT, THE SURGICAL TEAM HAD TO APPLY SUTURES AND CLIPS TO SECURE THE TISSUE AND PREVENT POTENTIAL INJURY.

    Patient problems: Tissue Breakdown

    MAUDE report 22394481 ↗
  • InjuryJul 3, 2025Failure to Form Staple; Failure to Form Staple

    ACCORDING TO THE REPORTER DURING A VIDEO-ASSISTED THORACOSCOPIC, DURING FIRING ON THE PULMONARY ARTERY THE FIRING PROCEEDED AS NORMAL. THOUGH IN THE MIDDLE OF THE STAPLE FIRING, THE SURGEON SAW DARK RED BLOOD AND THERE WERE MISSING STAPLES ALONG THE STAPLE LINE. THE STAPLE LINE WAS INCOMPLETE CENTRALLY. THE SURGEON PLACED A SPONGE STICK ON THE PULMONARY ARTERY AND HAD TO CONVERT TO A THORACOTOMY TO SUTURE THE MIDDLE PORTION TO THE STAPLE LINE WHERE THERE WERE NO STAPLES FORMED. THERE WAS A BLOOD LOSS OF ONE UNIT AND AN IMAGING WAS DONE. SURGICAL TIME WAS EXTENDED BY ONE HOUR AND HOSPITALIZATION WAS EXTENDED BY THREE DAYS.

    Patient problems: Great Vessel Perforation; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Unintended Radiation Exposure

    MAUDE report 22394001 ↗
  • MalfunctionJun 17, 2025Break; Break

    IT WAS REPORTED THAT DURING A LOBECTOMY, THE RELOAD INSTRUMENT BROKE. THE LOCK RING BROKE WHEN THE SURGEON APPLIED HIGH FORCE TO ARTICULATE THE RELOAD, RESULTING IN THE CONNECTION BETWEEN THE RELOAD AND THE SHORT ADAPTOR BREAKING. THE BROKEN PART DID NOT DISENGAGE. THE ISSUE WAS RESOLVED BY REPLACING THE SHORT ADAPTOR WITH ANOTHER ONE AFTER FIRING THE RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22220253 ↗
  • MalfunctionJun 5, 2025Failure to Fire; Failure to Fire

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER PRESSING THE GREEN BUTTON AND SQUEEZING THE HANDLE. THE DEVICE DID NOT FIRE. A NEW RELOAD WAS USED AND THE HANDLE WORKED WELL. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22154406 ↗

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

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.