ECHELON ENDOPATH EC45Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10705036001669), received between Jul 20, 2018 and Jul 3, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  TITLE : A COOPERATIVE APPROACH FOR TREATMENT OF ZENKER'S DIVERTICULUM. AUTHORS : DANIEL CASTANEDA, FRANCISCO FRANCO AZAR,ISHTIAQ HUSSAIN, LUIS F. LARA, RONNIE R. PIMENTE,GILBERTO ALEMAR,CANDACE HRELEC,JEFREY PONSKY, TOLGA ERIM CITATIONS : SURGICAL ENDOSCOPY. PAGES : 1-7. HTTPS://DOI.ORG/10.1007/S00464-021-08736-Z. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY, FAILURE RATE, AND SAFETY PROFILE OF A COOPERATIVE APPROACH BY A GASTROENTEROLOGIST AND OTOLARYNGOLOGIST IN THE TREATMENT OF ZENKER¿S DIVERTICULUM. SINGLE-CENTER RETROSPECTIVE STUDY OF PATIENTS ( N=63 ) WHO UNDERWENT A COOPERATIVE ENDOSCOPIC DIVERTICULECTOMY BY A GASTROENTEROLOGIST AND OTOLARYNGOLOGIST AT CLEVELAND CLINIC FLORIDA BETWEEN 2012 AND 2019.PATIENTS WERE PREDOMINANTLY MALES (63.5%) AND WHITE (84.1%), WITH MEAN AGE 73.5 YEARS (53¿95). MOST SUBJECTS PRESENTED DYSPHAGIA (98.4%), MOSTLY TO SOLIDS (79.4%). AN ENDOPATH 45 STAPLER (ETHICON ENDO-SURGERY, CINCINNATI, OH, USA) WAS ENGAGED ONTO THE MUSCULAR BAR AND SUBSEQUENTLY FIRED. IF NO MUSCULAR BAR DIVISION WAS ACHIEVED, A HARMONIC ENDOSCOPIC SCALPEL WAS USED TO CUT THE TISSUE OR ENDOPATH SCISSORS WERE USED TO CUT THE MIDLINE OF THE STAPLER AND A SECOND STAPLING PASS

  Patient problems: Insufficient Information

  MAUDE report 19666545 ↗
• MalfunctionAug 12, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE ECHELON DEVICE STUCK AFTER SECOND PRESS. THE PATIENT WAS NOT INJURED. OPERATION TIME HAS BEEN INCREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15216820 ↗
• MalfunctionJul 15, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A VATS PROCEDURE WHEN STAPLING (ECHELON 45 MANUAL)THE LOBE THE STAPLER WOULDN´T OPEN UP. DUE TO CONCERNS REGARDING IF SUFFICIENT CLIPS HAVE BEEN APPLIED OR NOT HE DIDN´T USE THE RETURN KNOB, BUT INSTEAD TAKING ANOTHER STAPLER AND PLACE IT BESIDE THE MALFUNCTIONING STAPLER AND THEN HE COULD TAKE IT "ALL OUT" (INCLUDING THE STAPLER THAT DIDN´T OPEN. PROCEDURE COMPLETED SUCCESSFULLY, WITH A SLIGHT DELAY. NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12173705 ↗
• InjuryJun 9, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL, "ONE OF OUR PATIENTS WHO HAD NEPHRECTOMY ONE YEAR AGO HAS HAD GENERALIZED RASH SINCE THE SURGERY. ECHELON ENDOPATH WAS USED FOR ARTERIAL AND VENOUS STAPLING."

  Patient problems: Hypersensitivity/Allergic reaction; Rash

  MAUDE report 11964970 ↗
• InjuryMay 19, 2021Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, WHEN PERFORMING THORACOSCOPIC LOBECTOMY ON THE LEFT LOBE OF THE LUNG WHEN A VASCULAR ANASTOMOSIS WAS APPLIED TO THE A3 BRANCH OF THE ARTERY USING THE EC45 ECHELON AND ECR45W CASSETTE, THE CASSETTE WAS STITCHED AND THE STAPLES PARTED IN THE MIDDLE OF THE SUTURE. THIS LED TO BLEEDING, HAD TO TRANSFER THE OPERATION TO THE OPEN ONE AND APPLY A VASCULAR SUTURE USING SUTURE MATERIAL. THE PATIENT IS ALL RIGHT, HE WAS DISCHARGED HOME. THE ECHELON IS NEW FROM THE PACKAGE, THE FIRST STITCHING ON THE VEIN WAS SUCCESSFUL. THE SECOND ON THE BRANCH OF THE ARTERY, THE CASSETTE DID NOT FORM AN ADEQUATE SUTURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11852021 ↗
• InjuryMay 18, 2021Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN PERFORMING THORACOSCOPIC LOBECTOMY ON THE LEFT LOBE OF THE LUNG WHEN A VASCULAR ANASTOMOSIS WAS APPLIED TO THE A3 BRANCH OF THE ARTERY USING THE EC45 ECHELON AND ECR45W CASSETTE, THE CASSETTE WAS STITCHED AND THE STAPLES PARTED IN THE MIDDLE OF THE SUTURE, WHICH LED TO BLEEDING, HAD TO TRANSFER THE OPERATION TO THE OPEN ONE AND APPLY A VASCULAR SUTURE USING SUTURE MATERIAL. THE PATIENT IS ALL RIGHT, HE WAS DISCHARGED HOME. THE ECHELON IS NEW FROM THE PACKAGE, THE FIRST STITCHING ON THE VEIN WAS SUCCESSFUL, THE SECOND ON THE BRANCH OF THE ARTERY THE CASSETTE DID NOT FORM AN ADEQUATE SUTURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11841943 ↗
• MalfunctionJul 20, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE KNIFE CUTS INTO THE MAGAZINE. PLASTIC PARTS FROM THE MAGAZINE FOUND IN THE INSTRUMENT MOUTH. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707815 ↗
• MalfunctionJul 20, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE KNIFE CUTS INTO THE MAGAZINEPLASTIC PARTS FROM THE MAGAZINE FOUND IN THE INSTRUMENT MOUTH. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707778 ↗
• MalfunctionJul 20, 2018Material Protrusion/Extrusion

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE KNIFE CUTS INTO THE MAGAZINE PLASTIC PARTS FROM THE MAGAZINE FOUND IN THE INSTRUMENT MOUTH. NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7707756 ↗