ENDOPATH 6R45BRecalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10705036000846), received between Dec 6, 2017 and Aug 21, 2025 — classified as 3 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (19 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 47 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: DE GIACOMO T, FRANCIONI F, VENUTA F, TRENTINO P, MORETTI M, RENDINA EA, COLONI GF. COMPLETE MECHANICAL CERVICAL ANASTOMOSIS USING A NARROW GASTRIC TUBE AFTER ESOPHAGECTOMY FOR CANCER. EUR J CARDIOTHORAC SURG. 2004 NOV;26(5):881-4. DOI: 10.1016/J.EJCTS.2004.07.024. PMID: 15519175. THE AIM OF THIS STUDY WAS TO TRYING TO REDUCE THE INCIDENCE OF THIS COMPLICATION, WE DESCRIBE OUR TECHNIQUE OF CERVICAL ESOPHAGOGASTRIC ANASTOMOSIS USING ENDOSCOPIC LINEAR STAPLER WHICH SEEMS TO REDUCE THE INCIDENCE OF FIBROUS STRICTURE FORMATION AFTER RESECTION OF ESOPHAGEAL CANCER. BETWEEN MARCH 2000 AND JUNE 2003, A TOTAL OF 26 PATIENTS WITH RESECTABLE ESOPHAGEAL CANCER UNDERWENT ESOPHAGECTOMY WERE INCLUDED IN THE STUDY. THESE PATIENTS INCLUDES 15 MALES AND 11 FEMALES. WITH A MEAN AGE OF 54.3 YEARS, RANGING FROM 43 TO 72 YEARS. THESE PATIENTS TREATED WITH ENDOSCOPIC LINEAR STAPLER (ETS45 BLUE CARTRIDGE, ETHICON ENDO-SURGERY) AND ARE PLACED ACROSS THE TWO OPPOSITE WALLS WITH THE ANVIL ON THE ESOPHAGEAL LUMEN AND THE CARTRIDGE IN THE GASTRIC TUBE. FOLLOW-UP OF AT LEAST 3 MONTHS WAS RECORDED FOR EVERY PATIENT REGAR

  Patient problems: Failure to Anastomose; Insufficient Information; Necrosis; Wound Dehiscence

  MAUDE report 22862508 ↗
• MalfunctionNov 19, 2024Mechanical Jam; Ejection Problem; Mechanical Jam; Ejection Problem

  IT WAS REPORTED THAT DURING A TOTAL GASTRECTOMY, ADJUSTING KNOB WAS LOOSER THAN USUAL. THE DETAILS ARE UNKNOWN AT THIS TIME, SO IT IS BEING CONFIRMED. 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 20724760 ↗
• MalfunctionNov 19, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ENT PHARYNGEAL POUCH THE [PATIENT HAS PERFORATED ESOPHAGUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20723766 ↗
• MalfunctionNov 12, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN ENT PHARYNGEAL POUCH THE PATIENT HAS PERFORATED ESOPHAGUS ¿BACK IN (B)(6) 2024 WE CARRIED OUT A PHARYNGEAL POUCH STAPLING USING THE ENDO PATH ETS45 3.5MM STAPLES. HOWEVER, ON THIS OCCASION THERE HAS BEEN AN INCIDENT, WHERE THE PATIENT SUFFERED A PERFORATED ESOPHAGUS¿.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667585 ↗
• MalfunctionOct 21, 2024Failure to Form Staple; Failure to Fire; Difficult to Open or Close; Failure to Form Staple; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT THE "STAPLE LOAD MISFIRED IN THE PATIENT, NOT ALL STAPLES EJECTED PROPERLY. ABLE TO SAFELY REMOVE STAPLE LOAD FROM THE PATIENT. SURGEON DID NOT INDICATE ANY COMPLICATIONS." THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20496732 ↗
• MalfunctionJun 3, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT WHEN THE RELOAD WAS OPENED IT WAS NOTICED THAT IT WAS BROKEN. ANOTHER RELOAD WAS OPENED TO CONTINUE WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449495 ↗
• MalfunctionDec 28, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE STAPLER MALFUNCTIONED, FIRED, BUT DID NOT STAPLE, REQUIRING REPLACEMENT OF THE STAPLER AND LOAD. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414909 ↗
• MalfunctionAug 15, 2023Failure to Fire; Appropriate Device Problem Term/Code Not Available; Failure to Fire; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, WHEN ATTEMPTING TO FIRE THE DEVICE NOTHING HAPPENED. NO STAPLES WERE DEPLOYED AND THE KNIFE DID NOT CUT. WHEN THE STAPLER WAS OPENED IT WAS NOTICED THE CARTRIDGE WAS EMPTY. A NEW CARTRIDGE WAS PLACED IN THE DEVICE TO COMPLETE THE FIRING. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17549918 ↗
• MalfunctionJun 13, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE CLIPS FELL OUT OF THE MAGAZINE UNFORMED IN THE SITU BEFORE THE TRIGGER COULD BE RELEASED. NO CLIPS REMAIN IN PATIENT. NO PATIENT HARM WAS REPORTED. A NEW MAGAZINE DID NOT SHOW THIS ERROR AND PROCEDURE FINISHED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117621 ↗
• MalfunctionMay 2, 2023Structural Problem; Structural Problem

  IT WAS REPORTED THAT BEFORE FIRING THE SURGEON NOTICES THAT THE CARTRIDGE HAS STAPLES THAT CAME OUT OF IT IN THE PROXIMAL PART. USED ANOTHER CARTRIDGE TO FINISH PROCEDURE. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16854901 ↗
• MalfunctionApr 10, 2023Unintended Ejection; Unintended Ejection

  IT WAS REPORTED, THAT AFTER PUTTING THE RELOAD INSIDE THE CLAMP. THE SURGEON CLOSED THE CLAMP ON THE TISSUES, BUT THE STAPLES CAME OFF WITHOUT ACTION FROM THE SURGEON. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709271 ↗
• MalfunctionApr 4, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS THE DEVICE FIRED BUT NO STAPLES WERE DISCHARGED. IT WAS DISCOVERED THE RELOAD WAS EMPTY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673309 ↗
• MalfunctionDec 15, 2022Unintended Ejection; Unintended Ejection

  IT WAS REPORTED THAT THE LOAD 6R45B PLACED IN THE ATS45 STAPLER AND WHEN INTRODUCED INTO THE CAVITY, THE LOAD 6R45B STAPLES FELL OPEN INTO THE ABDOMINAL CAVITY BEFORE BEING TRIGGERED BY THE STAPLER. STAPLES WERE REMOVED FROM THE CAVITY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15990667 ↗
• MalfunctionOct 12, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PARTIAL CYSTECTOMY PROCEDURE, THEY WERE GOING TO FIRE THE STAPLER ACROSS THE COLON AND THE PROXIMAL END OF THE RELOAD FIRED AS NORMAL. THE DISTAL END, THE STAPLES CAME OUT UNFORMED, YET THE KNIFE STILL ADVANCED. THEY DID END UP STAPLING WITH TWO OTHER RELOADS THAT WERE SUCCESSFUL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15586115 ↗
• MalfunctionOct 11, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PARTIAL CYSTECTOMY PROCEDURE, THEY WERE GOING TO FIRE THE STAPLER ACROSS THE COLON AND THE PROXIMAL END OF THE RELOAD FIRED AS NORMAL. THE DISTAL END, THE STAPLES CAME OUT UNFORMED, YET THE KNIFE STILL ADVANCED. THEY DID END UP STAPLING WITH TWO OTHER RELOADS THAT WERE SUCCESSFUL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583726 ↗
• MalfunctionOct 11, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE PARTIAL CYSTECTOMY PROCEDURE, THEY WERE GOING TO FIRE THE STAPLER ACROSS THE COLON AND THE PROXIMAL END OF THE RELOAD FIRED AS NORMAL. THE DISTAL END, THE STAPLES CAME OUT UNFORMED, YET THE KNIFE STILL ADVANCED. THEY DID END UP STAPLING WITH TWO OTHER RELOADS THAT WERE SUCCESSFUL. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583116 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN USING THE RELOAD, THE PATIENT HAD SIGNIFICANT BLEEDING IN THE STAPLE LINE THAT WAS CIRCUMVENTED WITH CAUTERIZATION PLUS USE OF SUTURE THREAD. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15538223 ↗
• MalfunctionMar 17, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE RELOAD FAILED IN THE ACT OF STAPLING. RELOAD LOCKED AND IT DID NOT STAPLE OR CUT. EXTRA LAPAROSCOPIC RELOAD WAS USED BECAUSE THE FIRST ONE FAILED IN THE STAPLING. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13790992 ↗
• MalfunctionMar 3, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, THE DEPLOYED STAPLES WERE UNFORMED. THE SAME ISSUE OCCURRED IN TWO CARTRIDGES. THE DEVICE WAS USED ON THE LUNG PARENCHYMA. 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 13662273 ↗
• MalfunctionMar 3, 2022Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A THORACOSCOPIC PNEUMONECTOMY, THE DEPLOYED STAPLES WERE UNFORMED. THE SAME ISSUE OCCURRED IN TWO CARTRIDGES. THE DEVICE WAS USED ON THE LUNG PARENCHYMA. 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 13661304 ↗
• MalfunctionFeb 3, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A RESPIRATORY SURGERY, THE KNIFE DID NOT MOVE FORWARD. 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 13443935 ↗
• MalfunctionJan 20, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE COULD NOT BE FIRED AT THE 1ST FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13309606 ↗
• MalfunctionNov 11, 2021Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING A UROLOGICAL SURGERY, THE FIRING FORCE WAS HIGHER THAN EXPECTED AT THE 1ST FIRING. ANOTHER CARTRIDGE 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 12800686 ↗
• MalfunctionOct 26, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLER HAS BEEN LOADED AND INSERTED THROUGH THE TROCAR. AS SOON AS THEY WERE WITHIN THE STRUCTURES THEY CLOSED THE STAPLER BUT FIRING WAS NOT ABLE. THEY REOPENED THE STAPLER AND USED A COMPLETE NEW PRODUCT. IT HAS BEEN OBSERVED THAT THE FIRST 6-8 DRIVERS WERE VISIBLE (IN ORANGE) WHICH IS AN INDICATOR, THAT THE STAPLER HAS BEEN FIRED PARTIALLY. LOT NUMBER OF THE RELOAD NOT AVAILABLE. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697906 ↗
• MalfunctionOct 22, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLE DID NOT FIRE PROPERLY. THE PROCEDURE WAS DELAYED BUT COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12685077 ↗