Tri-Staple 2.0 SIGRADXTRecalls & reported problems

Summary

The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 10884521543751), received between Dec 22, 2017 and Aug 26, 2026 — classified as 5 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (31 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 70 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50461220 ↗
• MalfunctionMar 12, 2026Misfire; Unintended Movement

  IT WAS REPORTED THAT DURING USE OF THE 15MM RELOAD WITH A MANUAL HANDLE, THE DEVICE PARTIAL FIRED, AND THE HANDLE MADE CRACKING SOUNDS WITH UNCONTROLLED ROTATION. THE DEVICE WAS REPLACED WITH A NEW HANDLE AND RELOADS, WHICH COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24577122 ↗
• MalfunctionMar 10, 2026Unintended Movement; Firing Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDLE WAS DIFFICULT TO FIRE, MADE A STRANGE NOISE, AND EXPERIENCED UNCONTROLLED ROTATION. THE DEVICE WAS REPLACED, AND A SECOND MANUAL HANDLE AND EXTRA RELOADS WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563079 ↗
• MalfunctionSep 17, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE FIRING COULD NOT BE DONE AT ALL. 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 23077794 ↗
• MalfunctionSep 15, 2025Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A RIGHT LOWER LOBE RESECTION, DURING PARTIAL RESECTION OF THE RIGHT LOWER LOBE, THE KNIFE ADVANCED UNTIL THE END, BUT THE RESECTION AND THE STAPLING WERE NOT PERFORMED. A SECOND RELOAD WAS ALSO TAKEN OUT, THE STAPLER INDICATED THAT IT WAS IN ZONE THREE DURING CLAMPING, BUT THE RESULT WAS THE SAME. A BLACK 60MM RELOAD WAS TAKEN OUT AND THE RESECTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058161 ↗
• MalfunctionSep 15, 2025Misfire; Failure to Fire; Misfire; Failure to Fire

  ACCORDING TO THE REPORTER IN A RIGHT LOWER LOBE RESECTION, DURING PARTIAL RESECTION OF THE RIGHT LOWER LOBE, THE KNIFE ADVANCED UNTIL THE END. BUT THE RESECTION AND THE STAPLING WERE NOT PERFORMED. A SECOND RELOAD WAS ALSO TAKEN OUT, THE STAPLER INDICATED THAT IT WAS IN ZONE THREE DURING CLAMPING BUT THE RESULT WAS THE SAME. A BLACK 60MM RELOAD WAS TAKEN OUT AND THE RESECTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058091 ↗
• MalfunctionSep 2, 2025Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PULMONARY RESECTION, THE USER WAS ABLE TO PRESS THE GREEN BUTTON, AND THE FIRING COULD NOT BE PERFORMED AT ALL. ANOTHER NEW RELOAD OF THE SAME PRODUCT WAS CONNECTED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22945510 ↗
• MalfunctionMay 28, 2025Failure to Form Staple; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPY RESECTION OF RIGHT LUNG MALIGNANT TUMOR, WHILE ON RIGHT PULMONARY PARENCHYMA RESECTION, THE STAPLES BECAME UNFORMED, LEAVING AN UNFIRED STAPLE IN THE CARTRIDGE. AN ADDITIONAL RESECTION WAS PERFORMED, AND ADDITIONAL SUTURING WAS DONE WITH A STAPLER.

  Patient problems: Tissue Breakdown

  MAUDE report 22099693 ↗
• MalfunctionFeb 25, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A SIGMOIDECTOMY, THERE WERE FIRING ISSUES WITH THE MANUAL STAPLER. THE SURGEON SQUEEZED THE HANDLE THREE TIMES AND THEN PULLED THE BLACK KNOB BACK TO OPEN THE JAWS, A FEW STAPLES WERE DEPLOYED AND IT DID NOT CUT. THE ISSUE OCCURRED DURING THE TRANSECTION OF THE SIGMOID. TO RESOLVE THE ISSUE, THE DEVICE WAS REPLACED WITH A GREEN RELOAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463397 ↗
• MalfunctionOct 17, 2024Difficult to Remove; Failure to Form Staple; Failure to Cut; Difficult to Remove; Failure to Form Staple; Failure to Cut

  ACCORDING TO THE REPORTER, DURING THE EXPLORATORY LAPAROTOMY WITH SIGMOID RESECTION, THE SHIPPING WEDGE WAS DIFFICULT FOR THE SCRUB TECH TO REMOVE. THE RELOAD WAS THEN PROPERLY LOADED ONTO ADAPTER WITH EASE. THE RELOAD WAS THEN PLACED AROUND SIGMOID TISSUE, WHEN ON TRANSECTION OF THE SIGMOID COLON, THE POWERED DEVICE READ ZONE 2 ON THE OLED SCREEN. SURGEON WAITED 30 SECONDS TO ALLOW EDEMA TO DISPERSE FROM TISSUE PRIOR TO FIRING. THE SAFETY BUTTON WAS PRESSED AND FIRED. ONCE RELOAD SIGNALED COMPLETED FIRING THE SURGEON PRESSED UP ON THE DEVICE TOGGLE TO RETRACT KNIFE BLADE, OPEN JAW OF RADIAL RELOAD AND REMOVE RELOAD FROM TISSUE. UPON DOING SO, THE SURGEON REALIZED THE KNIFE BLADE NEVER CUT THE TISSUE. LOOKING AT THE RELOAD, IT LOOKED AS IF THERE WERE STAPLES THAT WERE DEPLOYED PROPERLY, AND SOME HAD NOT BEEN DEPLOYED INTO THE TISSUE BECAUSE THEY ARE STILL IN THE RELOAD BEING SENT BACK. SOME ARE MALFORMED AS THEY ARE STICKING OUT OF THE RELOAD. THE POWER HANDLE NEVER ONCE SIGNALED EXCESSIVE FORCE READING. THE FIRING STAYED ON THE LINE OF ZONE 2 AND 3. TO RESOLVE THE ISSUE, ADDITIONAL RESECTING AND RE-STAPLING WAS PERFORMED.

  Patient problems: Tissue Breakdown

  MAUDE report 20470009 ↗
• InjuryApr 11, 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 LOW ANTERIOR RESECTION, WHEN THE SURGEON WAS ABOUT TO REMOVE THE RECTUM WITH A PURPLE 60MM RELOAD, THE LOADING UNIT COULD NOT BE CLOSED DUE TO TISSUE BEING THICK. THEN, THE BLACK LOADING UNIT WAS CONNECTED, AND THE GREEN BUTTON WAS PRESSED, BUT THE HANDLE COULD NOT BE TRIGGERED, AND THE DEVICE DID NOT FIRE. THERE WAS ALSO A SMALL PLASTIC PART FROM THE LOADING UNIT THAT BROKE OFF. THE SURGERY WAS CONVERTED INTO AN OPEN PROCEDURE, EXTENDED THE INCISION, AND EXPOSED THE RECTUM WITH A STAPLER FROM A DIFFERENT MANUFACTURER. SURGICAL TIME WAS EXTENDED FOR MORE THAN 30 MINUTES. THE PURPLE RELOAD WAS ABLE TO BE USED WITH NO ISSUE WITH A DIFFERENT HANDLE.

  Patient problems: Laceration(s)

  MAUDE report 19088244 ↗
• MalfunctionApr 4, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PARTIAL RESECTION OF LUNG, WHEN THE PULMONARY PARENCHYMA WAS RESECTED, THE FIRING WAS ATTEMPTED AS USUAL, BUT THE STAPLER COULD NOT BE FIRED. 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 19047756 ↗
• MalfunctionFeb 12, 2024Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC SURGERY, IN PULMONARY RESECTION, THE USER WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. HOWEVER, THE DEVICE DID NOT FIRE. TO RESOLVE THE ISSUE, ONLY THE RELOAD WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18692061 ↗
• MalfunctionFeb 7, 2024Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC PARTIAL PULMONARY RESECTION, HANDLE AND RELOAD WERE USED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF INTERSTITIAL PNEUMONIA, AND IT WAS INFORMED BY THE CUSTOMER THAT THE PULMONARY PARENCHYMA WAS EXTREMELY HARDENED. CLAMPING OF THIS PRODUCT ON THE TISSUE WAS MADE, SO THE HANDLE WAS VERY HARD WHEN FIRING WAS PERFORMED. THERE WAS POOR STAPLE MALFORMATION AND STAPLE LINE WAS INCOMPLETE PROXIMALLY. THE EXPANDED INCISION RANGE EXCEEDED 1 INCH (2.54 CM). ADDITIONAL RESECTION OF PULMONARY PARENCHYMA WAS PERFORMED TO FIX THE STAPLE LINE AND RESOLVE THE ISSUE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AS SCHEDULED AFTER THE SURGERY, BUT THE SURGERY TIME SEEMED TO HAVE TAKEN TWO HOURS LONGER THAN PLANNED DUE TO PROBLEMS WITH THIS HANDLE AND RELOAD.

  Patient problems: Tissue Breakdown

  MAUDE report 18662737 ↗
• MalfunctionDec 19, 2023Entrapment of Device; Misfire; Entrapment of Device; Misfire

  ACCORDING TO THE REPORTER, DURING AN OPEN LOW ANTERIOR RECTUM RESECTION, WHEN THE FIRING OF THE RELOAD BEGAN, THE DEVICE DID NOT CONTINUE AFTER A SMALL ADVANCE. ADDITIONALLY, THE JAWS OF THE RELOAD COULD NOT BE OPENED. THE SURGEON MANUALLY RETRACTS THE BLADE TO OPEN THE DEVICE. IT WAS NOTED THE BLACK DISTAL PART OF THE HANDLE SHAFT DISENGAGED FROM THE DEVICE AND THE SILVER SHAFT ALSO MOVED FORWARD, REVEALING THE RED INSIDE OF THE ROD. A COMPONENT ALSO FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED WITH THE HANDLE. TO COMPLETE THE CASE, A DEVICE FROM ANOTHER MANUFACTURER WAS USED. THE PROCEDURE TIME WAS ALSO EXTENDED FOR MORE THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360147 ↗
• MalfunctionDec 19, 2023Break; Firing Problem; Break; Firing Problem

  ACCORDING TO THE REPORTER, DURING THE LAPAROTOMY WITH PARTIAL PULMONARY RESECTION, ON THE RESECTION OF PULMONARY PARENCHYMA, THE FIRING FELT STIFF AND THERE WAS A STRANGE SOUND HEARD WITH THE HANDLE. A NEW HANDLE AND RELOAD WERE TAKEN OUT AND THE OPERATION WAS PERFORMED. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT FOUND THAT THERE WAS EGIA RELOAD THICK TISSUE. THE CLAMPING MECHANISM WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18358229 ↗
• MalfunctionAug 14, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN AN OPEN SIGMOID COLON RESECTION, WHEN STAPLING THE STUMP OF THE SIGMOID COLON, THE DEVICE CRACKED AND DID NOT FIRE. THE GREEN BUTTON WAS PRESSED, AND THE HANDLE WAS SQUEEZED BUT THE DEVICE COULD NOT BE FIRED. THE TISSUE THAT THE SURGEON WAS TRYING TO STAPLE TO REMOVE THE SIGMOID COLON WAS VERY THICK. THE SURGEON TRIED WITH TWO DIFFERENT HANDLES AND RELOADS, AND NEITHER WERE SUCCESSFUL. THE THICK TISSUE WAS VERY INFLAMED, SO THE SURGEON WAS NOT SURPRISED. THE SURGEON THEN DECIDED TO USE A BOVIE AND OVERSEW THE COLON TO REMOVE IT AND DID AN EXPECTED COLOSTOMY BAG.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17546813 ↗
• MalfunctionAug 14, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, IN AN OPEN SIGMOID COLON RESECTION, WHEN STAPLING THE STUMP OF THE SIGMOID COLON, THE DEVICE CRACKED AND DID NOT FIRE. THE GREEN BUTTON WAS PRESSED, AND THE HANDLE WAS SQUEEZED BUT THE DEVICE COULD NOT BE FIRED. THE TISSUE THAT THE SURGEON WAS TRYING TO STAPLE TO REMOVE THE SIGMOID COLON WAS VERY THICK. THE SURGEON TRIED WITH TWO DIFFERENT HANDLES AND RELOADS, AND NEITHER WERE SUCCESSFUL. THE THICK TISSUE WAS VERY INFLAMED, SO THE SURGEON WAS NOT SURPRISED. THE SURGEON THEN DECIDED TO USE A BOVIE AND OVERSEW THE COLON TO REMOVE IT AND DID AN EXPECTED COLOSTOMY BAG.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17546760 ↗
• InjuryAug 11, 2023Misfire; Device Displays Incorrect Message; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Misfire; Device Displays Incorrect Message; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC LOWER ANTERIOR RESECTION CONVERTED TO OPEN DUE TO DEVICE PROBLEM, WHEN FIRING THE RADIAL RELOAD ACROSS THE RECTUM, IT WOULD NOT FIRE ALL THE WAY DUE TO EXCESSIVE LOAD WARNING. THE RELOAD FIRED PARTIALLY. WHEN THE STAPLER WAS REMOVED, THE DEVICE TORE A BLOOD SUPPLY WHICH CAUSED THE PATIENT'S ABDOMEN TO FILL WITH BLOOD AND THE SURGEON HAD TO CONVERT THE PROCEDURE TO OPEN TO RESOLVE THE ISSUE. THE PATIENT HAD TO RECEIVE BLOOD DUE TO LOSS OF BLOOD. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES. THE CASE WAS FINISHED USING A LINEAR BLACK RELOAD.

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

  MAUDE report 17515899 ↗
• MalfunctionMay 15, 2023Break; Firing Problem; Break; Firing Problem

  ACCORDING TO THE REPORTER, DURING THE THORACOSCOPIC PARTIAL PULMONARY RESECTION, THE FIRST FIRING USING THE RADIAL BLACK RELOAD AND THE ULTRA SHORT HANDLE WAS SOMEHOW SUCCESSFULLY COMPLETED. THE DIFFICULTY WITH FIRING WAS BECAUSE THE LUNGS WERE THICK. ON THE SECOND FIRING, USING THE EXTRA THICK BLACK RELOAD AND ANOTHER ULTRA SHORT HANDLE WITH A DIFFERENT LOT NUMBER, THE TISSUE WAS CLAMPED AND THE FIRING WAS ATTEMPTED, BUT THE JAWS OF THE STAPLER DID NOT CLOSE, AND IT DID NOT ENTER IN THE FIRING MODE. ATTEMPTED TO REPLACED THE ULTRA SHORT HANDLE, BUT THE FIRING COULD NOT BE POSSIBLE, SO THE OPERATION WAS COMPLETED WITH ANOTHER COMPANY'S PRODUCT. IT WAS NOTED THE PATIENT HAD THICK TISSUE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE AND CLAMPING MECHANISM WAS DEFORMED WHICH IS INDICATIVE OF BEING APPLIED TO TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930490 ↗
• MalfunctionMay 3, 2023Entrapment of Device; Misfire; Device Displays Incorrect Message; Entrapment of Device; Misfire; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VIDEO-ASSISTED THORACOSCOPIC (VATS) IN RESPIRATORY SURGERY AND LUNG LOBECTOMY, WHEN THE POWER HANDLE WAS CONNECTED TO THE RELOAD, ZONE THREE WAS DISPLAYED. AFTER SEVERAL TIMES OF OPENING AND CLOSING THE JAWS AND THE TISSUE COMPRESSION, ZONE TWO WAS DISPLAYED AND  FIRING WAS PERFORMED. HOWEVER, WHEN THE FIRING HAS ADVANCED ONE-FIFTH OF ITS WAY THROUGH, THE TISSUE MAY BE TOO HARD, AND THE KNIFE AUTOMATICALLY RETRACTED AND RETURNED. THE DEVICE WAS FIXATED IN THE TISSUE BUT EVENTUALLY WAS REMOVED. AFTER THAT, THE SURGEON USED TWO BLACK 45MM RELOAD TO PERFORM THE RESECTION ON THE TISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865920 ↗
• MalfunctionMar 29, 2023Entrapment of Device; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MALIGNANT RECTAL TUMOR PROCEDURE, WHEN THE DEVICE WAS FIRED, THE JAWS CAME TO TOUCH THE TISSUE, BUT THE DEVICE DID NOT FIRE AND SOUNDED AS IF SOMETHING BROKE INSIDE. IT WAS NOTED THAT THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE ISSUE OCCURRED WITH TWO RELOADS AND ONE HANDLE. THIS LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME. 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 16635210 ↗
• MalfunctionMar 29, 2023Entrapment of Device; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC MALIGNANT RECTAL TUMOR PROCEDURE, WHEN THE DEVICE WAS FIRED, THE JAWS CAME TO TOUCH THE TISSUE, BUT THE DEVICE DID NOT FIRE AND SOUNDED AS IF SOMETHING BROKE INSIDE. IT WAS NOTED THAT THE SURGEON WAS UNABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. THE ISSUE OCCURRED WITH TWO RELOADS AND ONE HANDLE. THIS LED TO 30 MINUTES OR MORE EXTENDED SURGICAL TIME. 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 16635165 ↗
• MalfunctionJan 12, 2023Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PARTIAL PULMONARY RESECTION, DURING A PULMONARY PARENCHYMA RESECTION, THE FIRING STOPPED MIDWAY ON BOTH RELOADS, AND THE TIP OF THE STAPLE THAT STOPPED WAS IN U-SHAPE. A NEW RELOAD WAS USED WITH THE SAME HANDLE AND ADAPTER WHERE THE SURGEON CONTINUED THE SECOND FIRING WHERE THE FIRST FIRING STOPPED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16145771 ↗
• MalfunctionJan 12, 2023Misfire; Failure to Form Staple; Misfire; Failure to Form Staple

  ACCORDING TO THE REPORTER, DURING A LAPAROTOMY PARTIAL PULMONARY RESECTION, DURING A PULMONARY PARENCHYMA RESECTION, THE FIRING STOPPED MIDWAY ON BOTH RELOADS, AND THE TIP OF THE STAPLE THAT STOPPED WAS IN U-SHAPE. A NEW RELOAD WAS USED WITH THE SAME HANDLE AND ADAPTER WHERE THE SURGEON CONTINUED THE SECOND FIRING WHERE THE FIRST FIRING STOPPED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16145751 ↗

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-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-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, 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-1831-2019 · May 17, 2019 · Open, Classified
  EGIA45 CT AR MD THK REL, EGIA45CTAMT
• Z-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• 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-1835-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 45MM MEDIUM/ THIC , SIG45CTAMT
• 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