ENDOPATH ATS45NKRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705036001089), received between Jan 19, 2018 and Apr 16, 2026 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (25 reports).

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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Failure to Cut

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WAS STUCK AND COULD NOT BE USED NORMALLY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24899298 ↗
• InjurySep 16, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WENT TO FIRE FIRST TIME AND UNFORMED STAPLES COLLECTED IN THE BOTTOM. THEY RELOADED AND THE SAME THING HAPPENED AGAIN. THEN THEY ABORTED THE PROCDEURE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067050 ↗
• MalfunctionAug 15, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON TRIED TO FIRE THE DEVICE BUT HE COULD NOT PULL THE CLOSING TRIGGER AS IT WAS STIFF. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22817935 ↗
• MalfunctionAug 12, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, STAPLING WAS NOT COMPLETED AT ALL AND TRIGGER WAS NOT OPENED AFTER FIRING. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783906 ↗
• MalfunctionJul 30, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SURGEON USED ATS45NK WITH TR45W. WHEN HE TRIED TO PULL THE CLOSING TRIGGER, HE WAS NOT ABLE TO. THEN WHEN HE PULLED IT STRONGLY, THE CLOSING TRIGGER BROKE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664531 ↗
• MalfunctionMay 15, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT WORK WHEN SURGEON TRIED TO SQUEEZE THE FIRING TRIGGER. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030845 ↗
• MalfunctionMay 6, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN KIDNEY PROCEDURE, IT WAS OBSERVED THAT THE STAPLE FIRING DID NOT FUNCTION PROPERLY AS NO STAPLES WERE DEPLOYED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971274 ↗
• MalfunctionMay 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT FIRE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953965 ↗
• MalfunctionMar 8, 2024Failure to Fire; Material Integrity Problem; Failure to Fire; Material Integrity Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC KIDNEY TRANSPLANTATION, THE HANDLE DID NOT MOVE AT 1ST STROKE OF 1ST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866307 ↗
• MalfunctionFeb 14, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT ON SECOND FIRING, INSPECTED STAPLE LINE ALONG VEIN. AND NOTICED UNFORMED STAPLES. CLIPPED VESSEL. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705581 ↗
• MalfunctionFeb 8, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE STOPPED ON THE WAY OF FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667309 ↗
• MalfunctionJul 11, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT IN THE OPERATION, AFTER USING THE FIRST FIRING AND RELOAD CARTRIDGE. AND THEN NEXT FIRING STAGE, IT WAS NOT STAPLED. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17297570 ↗
• MalfunctionFeb 16, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A DEFECTIVE PRODUCT. STATED THERE WAS A HOLE THROUGH THE PACKAGING. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16386613 ↗
• MalfunctionOct 3, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE DEVICE WOULD NOT FIRE AFTER ASSEMBLE CARTRIDGE WITH BODY. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15527750 ↗
• InjuryMay 23, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THE PATIENT WITH APPENDICITIS UNDERWENT A LAPAROSCOPIC APPENDECTOMY AT CEDARS-SINAI MEDICAL CENTER. MEDICAL RECORDS PROVIDED INDICATE THAT A ¿BLUE LOAD CARTRIDGE ENDO STAPLER¿ WAS USED TO TRANSECT THE APPENDIX AT THE BASE, AND TWO WHITE LOADS WERE USED TO STAPLE ACROSS THE MESENTERY. A CLIP WAS PLACED TO ACHIEVE HEMOSTASIS AT THE STAPLE LINES. THE PATIENT WAS DISCHARGED THE NEXT DAY WITH NO ISSUES. THE PATIENT RETURNED TO THE HOSPITAL ON POD 5 WITH NAUSEA BUT WAS DISCHARGED AND RETURNED AGAIN ON POD 7 WITH NAUSEA, VOMITING, AND CRAMPY ABDOMINAL PAIN. HER LABS WERE NOTABLE FOR LEUKOCYTOSIS, AND HER CT SCAN WAS CONCERNING FOR HIGH GRADE SMALL BOWEL OBSTRUCTION. THE PATIENT THUS UNDERWENT AN EXPLORATORY LAPAROTOMY DURING WHICH THE SURGEON NOTED ¿A FOCAL POINT OF OBSTRUCTION WAS NOTED TO BE FROM A LOOSE STAPLE FROM THE PRIOR ENDO-STAPLER USED FOR HER APPENDECTOMY, WHICH CAUSED AN ADHESION FROM A PORTION OF THE SMALL BOWEL TO MESENTERY.¿ THE STAPLE WAS REMOVED AND ANOTHER LIKE IT WAS ALSO REMOVED. THE PRIOR APPENDECTOMY SITE WAS NOTED TO BE INTACT. THE PATIENT WAS DISCHARGED ON POD 13 IN STABLE CONDITION AFTER HAVING HER DIET SLOWLY ADVANCED AND NG TUBE REMOVED. EIG

  Patient problems: Abdominal Pain; Nausea; Obstruction/Occlusion; Vomiting

  MAUDE report 14480310 ↗
• MalfunctionApr 21, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT THERE WAS STAPLE MALFORMATION. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14171742 ↗
• MalfunctionFeb 28, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE DEVICE DIDN'T GET FIRED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13623836 ↗
• MalfunctionJul 29, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING RADICAL GASTRECTOMY FOR GASTRIC CANCER SURGERY, COULD NOT FIRE WHEN SEVERING JEJUNAL TISSUE . CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12245851 ↗
• MalfunctionMar 1, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE SURGEON TRIED TO FIRE THE DEVICE, BUT THE FIRING BUTTON DIDN'T WORK. IT WAS THE FIRST FIRE. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11394617 ↗
• MalfunctionJan 12, 2021Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROXIMAL GASTRECTOMY, THE STAPLES WERE NOT DEPLOYED AT THE 1ST FIRING. THE DEVICE WAS REMOVED FROM THE PATIENT AND ATTEMPTED TO OPEN THE JAWS, BUT THE CLOSING LEVER AND THE FIRING TRIGGER COULD NOT RETURN TO THE HOME POSITION. WHEN THE DEVICE WAS CHECKED, IT WAS FOUND ABOUT 2 STAPLES AT THE PROXIMAL END OF THE CARTRIDGE WERE PROTRUDED BUT NOT DEPLOYED. ADDITIONAL HAND SUTURE WAS PERFORMED TO COMPLETE THE CASE. THE DEVICE WAS USED BETWEEN THE ESOPHAGUS AND THE STOMACH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11154637 ↗
• MalfunctionNov 26, 2020Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT THE ATS45NK DEVICE DIDN¿T WORK AS EXPECTED. ON (B)(6) PROF WAS USING THIS IN A HEPATECTOMY CASE AND THE SECOND CLICK DIDN¿T APPEAR TO WORK PROPERLY. THE SURGEON STRUGGLED TO REMOVE THE DEVICE FROM THE PATIENT AND IT HADN¿T FIRED. THE PATIENT WAS UNHARMED AND THE CASE CONTINUED WITH THE SURGEON USING ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10910971 ↗
• MalfunctionNov 16, 2020Firing Problem

  IT WAS REPORTED THAT DURING THE RADICAL GASTRECTOMY FOR GASTRIC CANCER SURGERY, COULD NOT FIRE WHEN SEVERING SMALL INTESTINAL TISSUE ON THE 1ST FIRING WITH TR45W. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10848342 ↗
• MalfunctionNov 16, 2020Failure to Fire

  IT WAS REPORTED THAT DURING THE DISTAL RADICAL GASTRECTOMY FOR GASTRIC CANCER SURGERY, COULD NOT FIRE. CHANGED ATS45NK AND TR45W, STILL COULD NOT FIRE. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10843981 ↗
• MalfunctionOct 22, 2020Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A DISTAL RADICAL GASTRECTOMY FOR GASTRIC CANCER SURGERY, THE DEVICE WOULD NOT FIRE WHEN SEVERING SMALL INTESTINE TISSUE ON THE FIRST FIRING. CHANGED TO ANOTHER ATS45NK AND TR45W TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A THIRD DEVICE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10719058 ↗
• MalfunctionOct 22, 2020Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING THE DISTAL RADICAL GASTRECTOMY FOR GASTRIC CANCER SURGERY, COULD NOT FIRE WHEN SEVERING SMALL INTESTINE TISSUE ON THE 1ST FIRING. CHANGED ANOTHER ATS45NK AND TR45W TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. CHANGED THE NEW ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10719024 ↗