Tri-Staple 2.0 SIGTRS45AMTRecalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 10884521543645), received between Feb 19, 2018 and Sep 22, 2026 — classified as 9 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Misfire” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Misfire; Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50858909 ↗
• MalfunctionNov 8, 2024Misfire; Human-Device Interface Problem; Misfire; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING A VATS PROCEDURE, THERE WAS ISSUE AFTER FIRING. THE RELOAD WAS DIFFICULT TO REMOVE. THE USER MANAGED TO REMOVE THE STAPLER, REPLACED IT AND COMPLETED PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640659 ↗
• MalfunctionJun 27, 2024Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE FOUR RELOADS STOPPED IN THE MIDDLE OF THE FIRING DURING RECTAL RESECTION. THE SURGEON CHECKED THE SITUATION AT THAT TIME, BUT NONE OF THEM REMEMBERED WHAT WAS DISPLAYED ON THE POWER HANDLE DISPLAY, AND THE SURGEON SAID THAT THE GREEN BUTTON WAS FLASHING. SHOWED THE ERROR MESSAGE THAT THE THICKNESS WAS NOT APPLICABLE AND CHECKED IT WITH THE HEALTHCARE PROFESSIONAL, BUT THE ERROR DID NOT SEEM TO BE THAT ONE. EVEN AFTER SHOWING THEM THE LIST OF POSSIBLE DISPLAY ERROR MESSAGES, THE SURGEON SAID IT DID NOT SEEM TO BE ANY OF THOSE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630256 ↗
• MalfunctionJun 27, 2024Misfire; Mechanics Altered; Misfire; Mechanics Altered

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THE FOUR RELOADS STOPPED IN THE MIDDLE OF THE FIRING DURING RECTAL RESECTION. THE SURGEON CHECKED THE SITUATION AT THAT TIME, BUT NONE OF THEM REMEMBERED WHAT WAS DISPLAYED ON THE POWER HANDLE DISPLAY, AND THE SURGEON SAID THAT THE GREEN BUTTON WAS FLASHING. SHOWED THE ERROR MESSAGE THAT THE THICKNESS WAS NOT APPLICABLE AND CHECKED IT WITH THE HEALTHCARE PROFESSIONAL, BUT THE ERROR DID NOT SEEM TO BE THAT ONE. EVEN AFTER SHOWING THEM THE LIST OF POSSIBLE DISPLAY ERROR MESSAGES, THE SURGEON SAID IT DID NOT SEEM TO BE ANY OF THOSE. A NEW RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19630226 ↗
• MalfunctionOct 13, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING THE SECOND TO THE LAST STAPLING WITH A 45MM PURPLE REINFORCED RELOAD, THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE THREAD ON THE REINFORCEMENT SHEET SEEMED TO HAVE BEEN CAUGHT ON SOMETHING AND CAUSED THE HANDLE TO REQUIRE EXTRA FORCE TO FIRE. THE STAPLER MADE A CRACKING NOISE AT THE END OF THE FIRING AND COULD NO LONGER BE USED. A NEW STAPLE LINE WAS FIRED TO CONTINUE FROM THE END USING A NEW HANDLE AND RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17932635 ↗
• MalfunctionJul 26, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A VIDEO ASSISTED THORACOSCOPIC SURGERY BULLA RESECTION, WHILE AT PULMONARY PARENCHYMA RESECTION, THE TISSUE WAS CLAMPED AND AN ATTEMPT WAS MADE TO FIRE, HOWEVER, THE FIRING STOPPED WHEN IT ADVANCED ABOUT 0.5 CM. THE DEVICE FIXATED TO TISSUE WAS REMOVED IN THE USUAL WAY. THE STAPLE AND INSTRUMENT WERE REMOVED, AND IT WAS HANDLED BY CONNECTING A NEW RELOAD. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17402254 ↗
• MalfunctionJul 13, 2023Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC RIGHT LOWER PARTIAL LOBECTOMY, DURING SECOND FIRING IN THE PULMONARY PARENCHYMA IN THE LOWER RIGHT LOBE, A LOUD SOUND WAS MADE AND THE STAPLING COULD NOT BE DONE. THERE WERE ALSO BROKEN INTERNAL PARTS FROM THE HANDLE. A NEW HANDLE AND RELOAD WERE USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17318116 ↗
• MalfunctionMay 19, 2023Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A VIDEO-ASSISTED THORACIC (VATS) BULLECTOMY PROCEDURE, WHEN POWER HANDLE AND 45 MILLIMETER PURPLE RELOAD USED, THE RELOAD DID NOT DEPLOY STAPLES AT THE TIP. THE SURGEON ASSESSED STAPLE LINE AND DEEMED IT WAS OK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16969603 ↗
• MalfunctionDec 1, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A HARTMANN'S LAPAROTOMY, WHILE ON RECTAL RESECTION, A PLANNED TWO-TIME CUT WAS PERFORMED USING A MANUAL STAPLER AND RELOAD. THE FIRST SHOT WAS SUCCESSFUL BUT WHEN THE SECOND SHOT WAS FIRED USING THE SAME DEVICE, A CRACKING SOUND FROM THE HANDLE WAS HEARD SO IT WAS RELEASED AND THE REINFORCEMENT SHEET WAS CUT. THIRD SHOT WAS FIRED USING A NEW RELOAD AND SAME HANDLE BUT THE TEETH DID NOT ADVANCE ANY FURTHER AT THE INTERSECTION, IT WAS RELEASED AND THE REINFORCEMENT SHEET WAS ALSO CUT. FOR THE FOURTH SHOT, A NEW RELOAD WAS USED AGAIN AND THIS TIME, A POWERED STAPLER WAS USED BUT THE SAME ISSUES WITH THE TEETH WERE NOTED. THE ISSUES WERE RESOLVED WHEN A NEW POWERED STAPLER AND RELOAD WERE USED IN FIRING THE FIFTH SHOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15899209 ↗
• MalfunctionDec 1, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A HARTMANN'S LAPAROTOMY, WHILE ON RECTAL RESECTION, A PLANNED TWO-TIME CUT WAS PERFORMED USING A MANUAL STAPLER AND RELOAD. THE FIRST SHOT WAS SUCCESSFUL BUT WHEN THE SECOND SHOT WAS FIRED USING THE SAME DEVICE, A CRACKING SOUND FROM THE HANDLE WAS HEARD SO IT WAS RELEASED AND THE REINFORCEMENT SHEET WAS CUT. THIRD SHOT WAS FIRED USING A NEW RELOAD AND SAME HANDLE BUT THE TEETH DID NOT ADVANCE ANY FURTHER AT THE INTERSECTION, IT WAS RELEASED AND THE REINFORCEMENT SHEET WAS ALSO CUT. FOR THE FOURTH SHOT, A NEW RELOAD WAS USED AGAIN AND THIS TIME, A POWERED STAPLER WAS USED BUT THE SAME ISSUES WITH THE TEETH WERE NOTED. THE ISSUES WERE RESOLVED WHEN A NEW POWERED STAPLER AND RELOAD WERE USED IN FIRING THE FIFTH SHOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15897326 ↗
• MalfunctionDec 1, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A HARTMANN'S LAPAROTOMY, WHILE ON RECTAL RESECTION, A PLANNED TWO-TIME CUT WAS PERFORMED USING A MANUAL STAPLER AND RELOAD. THE FIRST SHOT WAS SUCCESSFUL BUT WHEN THE SECOND SHOT WAS FIRED USING THE SAME DEVICE, A CRACKING SOUND FROM THE HANDLE WAS HEARD SO IT WAS RELEASED AND THE REINFORCEMENT SHEET WAS CUT. THIRD SHOT WAS FIRED USING A NEW RELOAD AND SAME HANDLE BUT THE TEETH DID NOT ADVANCE ANY FURTHER AT THE INTERSECTION; IT WAS RELEASED AND THE REINFORCEMENT SHEET WAS ALSO CUT. FOR THE FOURTH SHOT, A NEW RELOAD WAS USED AGAIN AND THIS TIME, A POWERED STAPLER WAS USED BUT THE SAME ISSUES WITH THE TEETH WERE NOTED. THE ISSUES WERE RESOLVED WHEN A NEW POWERED STAPLER AND RELOAD WERE USED IN FIRING THE FIFTH SHOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896793 ↗
• MalfunctionOct 13, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LAPAROTOMY AND TOTAL ABDOMINAL GASTRECTOMY, AT THE TIME OF RESECTION, THE PHYSICIAN CONNECTED THE CARTRIDGE, FIXED IT TO THE JAW, PRESSED THE GREEN BUTTON AND TRIED TO FIRE, BUT THE KNIFE DID NOT ADVANCE. THE HANDLE WAS UNABLE TO BE SQUEEZED. A NEW DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THE PATIENT HAS HUMAN IMMUNODEFICIENCY VIRUS. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597186 ↗
• InjuryAug 25, 2022Misfire; Failure to Form Staple; Device Displays Incorrect Message; Detachment of Device or Device Component; Material Twisted/Bent; Misfire; Failure to Form Staple; Device Displays Incorrect Message; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING AN OPEN HARTMANN LAPAROTOMY, WHILE AT RECTAL RESECTION, FIRING WAS COMPLETED AS USUAL FOR THE ORAL INTESTINAL TRACT WITH THE RELOAD. WHEN FIRED AT THE ANAL SIDE WITH REINFORCED RELOAD, THE FIRING STOPPED MIDWAY DUE TO THE EXCESSIVE FORCE INDICATION. ANOTHER RELOAD WAS USED ADDITIONALLY, BUT THE FIRING STOPPED. THE GAP BETWEEN THE CARTRIDGE AND ADAPTER CONNECTION PART WAS FOUND TO BE OPEN MORE THAN USUAL AND IT WAS UNSTEADY. WHEN THE CONNECTION PART OF THE REINFORCED RELOAD WAS TOUCHED AFTER COLLECTING THE ACTUAL PRODUCT, IT WAS FOUND TO BE UNFIXED AND IT WAS IN BENT STATE. IT WAS STATED THAT THE SHORT ADAPTER CONNECTION PART BROKE OFF. IT WAS ALSO REPORTED THAT THE STAPLE LINE FOR ONE OF THE RELOAD WAS INCOMPLETE PROXIMALLY AND THE OTHER RELOAD CENTRALLY. THERE WAS POOR STAPLE FORMATION AND THE JAWS OF THE DEVICE LOCKED ON TISSUE BUT IT WAS REMOVED BY OPENING AS USUAL. ANOTHER DEVICE FROM OTHER MANUFACTURER WAS USED TO FIXED THE STAPLE LINE AND FOR ADDITIONAL RESECTION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15296484 ↗
• InjuryAug 25, 2022Entrapment of Device; Entrapment of Device

  THE COMPLAINT WAS NOTIFIED TO US BY TGA, DUE TO THIS WE WILL NOT BE ABLE TO FOLLOW UP WITH FURTHER INFORMATION. CLINICAL EVENT INFORMATION: DURING A LAPAROSCOPIC SLEEVE PROCEDURE, THE SIGNIA POWERSHELL WITH A 45 MM COVIDIEN TRISTAPLE RELOAD AND A SECOND FIRE WITH SEAM GUARD, WOULD NOT OPEN AFTER CUTTING AND STAPLING. THE MEDLINE REPRESENTATIVE WAS ATTENDING. A SOFT RE-BOOT WAS ATTEMPTED FOLLOWED UP BY A MANUAL DISENGAGEMENT WITH A MEDTRONIC 'ALAN KEY'. IT WAS NOT SUCCESSFUL. GENERAL TRACTION WAS REQUIRED TO REMOVE, RESULTING IN TRAUMATIC GASTROSTOMY TO STAPLE LINE. PATIENT OUTCOME/CONSEQUENCES: THE PATIENT WAS READMITTED FOR A LAPAROSCOPIC WASHOUT AND INSERTION OF DRAINS. DEVICE ANALYSIS RESULTS: CORRECTIVE/PREVENTATIVE ACTIONS: DETAILS OF SIMILAR EVENTS: NUMBER OF SIMILAR EVENTS: RATE OF SIMILAR EVENTS: COUNTRIES SIMILAR EVENTS ALSO OCCURRED: TYPE OF PROBLEM (LEVEL 1) TYPE OF PROBLEM (LEVEL 2) MECHANICAL JAM MECHANICAL PROBLEM CAUSE OF PROBLEM (LEVEL 1) CAUSE OF PROBLEM (LEVEL 2) NO FINDINGS AVAILABLE OUTCOME OF INVESTIGATION REVIEWED, FOR TRENDING PURPOSES ONLY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15294446 ↗
• MalfunctionAug 23, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORACIC SURGERY, THE STAPLER WAS UNABLE TO FIRE AND UNUSUAL NOISE HEARD WHEN ACTIVATED. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND WAS ABLE TO SQUEEZE THE HANDLE. A NEW INSTRUMENT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276134 ↗
• MalfunctionJun 2, 2022Entrapment of Device; Device Displays Incorrect Message; Failure to Fire; Entrapment of Device; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY, WHILE DOING AN INTERLOBAR FORMATION, THE INITIAL RELOAD DID NOT FIRE. THE SECOND RELOAD USED DID NOT FIRE AS WELL. IT WAS ALSO NOTED THAT THE JAWS OF THE DEVICE LOCKED ON TISSUE AND AN EXCLAMATION MARK APPEARED ON THE DISPLAY. THE DEVICE WAS REMOVED AND A THIRD RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577695 ↗
• MalfunctionJun 2, 2022Entrapment of Device; Device Displays Incorrect Message; Failure to Fire; Entrapment of Device; Device Displays Incorrect Message; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A THORACOSCOPIC LOBECTOMY, WHILE DOING AN INTERLOBAR FORMATION, THE INITIAL RELOAD DID NOT FIRE. THE SECOND RELOAD USED DID NOT FIRE AS WELL. IT WAS ALSO NOTED THAT THE JAWS OF THE DEVICE LOCKED ON TISSUE AND AN EXCLAMATION MARK APPEARED ON THE DISPLAY. THE DEVICE WAS REMOVED AND A THIRD RELOAD WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14577671 ↗
• MalfunctionJun 1, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC BYPASS AND Y-ROUX, DURING THE GASTRIC SECTION, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZED THE HANDLE BUT THE KNIFE AND STAPLES PUSHERS DID NOT WORK AND DID NOT RUN AHEAD. THERE WERE NO STAPLES DEPLOYED. THE FIRST FOUR LOADS WHERE USED WITH NO REINFORCED MATERIAL. THE SECOND THREE OR FOUR LOADS WERE USED WITH REINFORCEMENT. THE SURGEON HAD TO REPLACE SEVERAL CARTRIDGES AND HANDLE SINCE THEY DID NOT KNOW EXACTLY WERE WORKING UNAPPROPRIATED WAY AND TRIED ALL THE SUSPECTED RESPONSIBLE OF THE ISSUE. THE REPORTER WAS NOT SURE OF THE EXACT NUMBER OF HANDLE AND LOADS THAT WERE USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569099 ↗
• MalfunctionMar 23, 2022Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, AT FIRST FIRING AFTER CLAMPING THE TISSUE, THE DEVICE COULD NOT BE FIRED, SO IT WAS STOPPED TO BE USED. WHILE AT SECOND FIRING, THE DEVICE STOPPED IN THE MIDDLE OF FIRING, SO USING IT WAS STOPPED AGAIN. THE STAPLE LINE WAS INCOMPLETE AT THE CENTER AND WAS FIXED WHEN THE CARTRIDGE WAS REPLACED AND RE-SUTURED. THE NEW CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860481 ↗
• MalfunctionMar 21, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, AT FIRST FIRING AFTER CLAMPING THE TISSUE, THE DEVICE COULD NOT BE FIRED, SO IT WAS STOPPED TO BE USED. WHILE AT SECOND FIRING, THE DEVICE STOPPED IN THE MIDDLE OF FIRING, SO USING IT WAS STOPPED AGAIN. THE STAPLE LINE WAS INCOMPLETE AT THE CENTER AND WAS FIXED WHEN THE CARTRIDGE WAS REPLACED AND RESUTURED. THE NEW CARTRIDGE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13841362 ↗
• MalfunctionFeb 17, 2022Failure to Fire; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRECTOMY, AN ATTEMPT WAS MADE TO USE THE DEVICE, THE STAPLER WAS UNABLE TO FIRE, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON AND SQUEEZE THE HANDLE. 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 13549210 ↗
• MalfunctionDec 17, 2021Misfire; Separation Failure; Misfire; Separation Failure

  ACCORDING TO THE REPORTER, DURING AN INTESTINAL RESECTION IN AN OPEN ABDOMINAL SURGERY, THE JAWS DID NOT OPEN BECAUSE THE SHEET OF REINFORCEMENT MATERIAL DID NOT DISENGAGE FROM THE JAWS AFTER SQUEEZING THE HANDLE AND PERFORMING THE FIRING. SUTURE WAS CUT WITH SCISSORS TO RESOLVE THE ISSUE. NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT IS THAT RELOAD WAS PARTIALLY FIRED AND THE INVESTIGATION DETECTED AN THE BUTTRESS WAS TORN AND DISLODGED FROM THE DISTAL END ON THE ANVIL SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13024242 ↗
• MalfunctionNov 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC THORACOSCOPIC LOBECTOMY, THE EVENT WAS FOUND WHEN THE JAWS WERE OPENED IN THE CHEST CAVITY, WHEN USING THE FIRST RELOAD IT WAS FOUND THAT THE SHEET HAD COME OFF DUE ON THE TIP OF THE ANVIL. THE SECOND ONE WAS OPENED TO REPLACE THE CARTRIDGE, THE ANCHORING SUTURE ON THE TIP OF THE ANVIL HAD COME OFF FROM THE BEGINNING OF THE SECOND ONE AND THE SHEET HAD COME OFF, SO THE USE OF THE SECOND ONE WAS ALSO STOPPED. ANOTHER PRODUCT WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12884084 ↗
• MalfunctionNov 11, 2021Misfire; Noise, Audible; Misfire; Noise, Audible

  ACCORDING TO THE REPORTER, DURING RESECTION OF LUNG IN A THORACOSCOPIC PULMONARY PARTIAL RESECTION, A DAMAGED SOUND WAS GENERATED FROM THE HANDLE AND THE FIRING STOPPED HALFWAY. A NEW RELOAD AND HANDLE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12797238 ↗
• MalfunctionNov 7, 2021Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY, ON ANASTOMOSIS, THE DEVICE DID NOT FIRE. IT WAS ALSO NOTED THAT THE THREAD AT THE TIP OF THE RELOAD CAME OFF. ANOTHER PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12763172 ↗

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-1833-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
• Z-1834-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
• 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-1836-2019 · May 17, 2019 · Open, Classified
  SIGNIA TRI-STAPLE 2.0 CURVED TIP 60MM MEDIUM/ THIC , SIG60CTAMT
• 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-1828-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING EXTRA THICK SULU, Item code EGIA60AXT
• Z-1827-2019 · May 17, 2019 · Open, Classified
  EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT
• Z-1830-2019 · May 17, 2019 · Open, Classified
  EGIA 60 CURVED TIP ART MED THICK SULU, EGIA60CTAMT
• Z-1829-2019 · May 17, 2019 · Open, Classified
  EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
• 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