ECHELON ENDOPATH LONG60ARecalls & reported problems

Summary

The FDA's MAUDE database contains 253 adverse event reports that list this exact device (DI 10705036002444), received between Dec 11, 2017 and Sep 17, 2026 — classified as 2 deaths, 22 injuries, 229 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (78 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 253 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Failure to Fire

  It was reported that during an unspecified surgical procedure, it was observed that the device could not be fired. Changed to a new one to complete the procedure. There was no patient consequence nor surgical delay reported. No additional information provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806225 ↗
• MalfunctionJun 1, 2026Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A ROBOTIC LOBECTOMY PROCEDURE, THE SURGEON FIRED THE STAPLER AND IT JAMMED AND COULD NOT BE OPENED. THE JAWS COULD NOT BE OPENED, AND A NEW DEVICE WAS REQUIRED TO CONTINUE THE PROCEDURE. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 45 MINUTES. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 25351261 ↗
• MalfunctionMay 28, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25318677 ↗
• MalfunctionApr 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE HAD AN UNSPECIFIED MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915643 ↗
• MalfunctionApr 9, 2026Mechanical Jam; Noise, Audible

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, A CRACKING SOUND WAS HEARD AT FIRST FIRING. STAPLE LINE AND CUT WERE FINISHED AND SOLID, BUT THE KNIFE DID NOT COME BACK. THE SURGEON WAS ABLE TO REMOVE THE STAPLED TISSUE WITHOUT DAMAGE, BUT OVERSEWED FOR SAFETY REASONS. A NEW STAPLER WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24832114 ↗
• MalfunctionMar 24, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE JAMMED AND DID NOT OPEN. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674814 ↗
• MalfunctionMar 17, 2026Component or Accessory Incompatibility; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, IT WAS OBSERVED THAT THEY COULD NOT OPEN THE JAW AFTER FIRING. THEY CUT OFF THE TISSUE AND REMOVED THE DEVICE TOGETHER WITH THE TROCAR. SUTURE SEWING WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619765 ↗
• MalfunctionMar 10, 2026Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE TISSUE DID NOT HOLD NOR CLOSE DURING RESECTION. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24558636 ↗
• MalfunctionFeb 18, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THERE WAS AN INCOMPLETE ROW OF STAPLES DISTAL OVER A SHORT DISTANCE. NEXT ROW OF STAPLES WAS PARALLEL DIRECTLY BELOW THE FIRST ROW OF STAPLES. SLIGHTLY LAPPING IN LENGTH. THUS GENERATED A FLAWLESS CONTINUOUS CLOSING CLAMP THREAD. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377791 ↗
• MalfunctionNov 5, 2025Failure to Fire; Difficult to Open or Close; Failure to Fire; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE, IT WAS OBSERVED THAT THE DEVICE DID NOT ADVANCE THE BLADE NOR STAPLES. IT WAS FURTHER REPORTED THAT THE DEVICE WOULD LOCK WHEN OPENING THAT THEY HAD TO TAKE A GRASPER TO FORCE OPEN THE JAW. THEY WERE ABLE TO REMOVE IT AND CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477151 ↗
• MalfunctionOct 17, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, IT WAS OBSERVED THAT THE STAPLER WAS BLOCKED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323917 ↗
• MalfunctionOct 17, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE, IT WAS OBSERVED THAT THE STAPLER WAS BLOCKED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23323916 ↗
• MalfunctionAug 19, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE ECHELON FLEX CLAMP WAS COMPLETELY LOCKED INSIDE THE PATIENT IN THE STAPLING POSITION WITH NO POSSIBILITY OF UNLOCKING IT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22843628 ↗
• MalfunctionAug 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER FIRED BUT DID NOT CLOSE THE TISSUE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22834409 ↗
• MalfunctionAug 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE TISSUE MOVED DURING FIRING AND ANASTOMOSIS WAS NOT PERFORMED CORRECTLY. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828371 ↗
• InjuryAug 13, 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: ISHIYAMA Y, HIRANO Y, SASAKI M, AKUTA S, YOSHIZAWA M, YAMATO M, NAKANISHI A, MINAGAWA Y, HAYASHI H, FUJII T, OKAZAKI N, ISHII T, HIRANUMA C. END-TO-END ANASTOMOSIS WITH ECHELON ENDOPATH¿ STAPLE LINE REINFORCEMENT FOR RIGHT-SIDED COLON CANCER: SAFETY AND FEASIBILITY. IN VIVO. 2025 MAY-JUN;39(3):1573-1579. DOI: 10.21873/INVIVO.13957. PMID: 40294993; PMCID: PMC12041969. THE AIM OF THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF FEEA WITH SLR COMPARED TO CONVENTIONAL FEEA IN ELECTIVE RIGHT-SIDED COLON CANCER SURGERY. BETWEEN FEBRUARY 2019 AND DECEMBER 2022, A TOTAL OF 159 (SURGICAL TECHNIQUE GROUP; 90 AND NON SURGICAL TECHNIQUE GROUP; 69) CONSECUTIVE PATIENTS WHO UNDERWENT ELECTIVE SURGERY FOR RIGHT-SIDED COLON CANCER. ECHELON FLEX (EES) WAS USED TO DISSECT AND ANASTOMOSED THE ILEUM AND COLON IN SURGICAL TECHNIQUE (SLR GROUP), WHILE IT WAS USED TO CLOSED THE COMMON HOLE IN NON-SLR. WHILE ECHELON ENDOPATH (EES) WAS USED TO CLOSED THE COMMON HOLE. REPORTED COMPLICATIONS: ECHELON FLEX (EES), ECHELON ENDOPATH (EES, SLR GROUP (N=90), NON SLR GROUP (N=69). SLR GROUP (N=90), POST

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22797478 ↗
• InjuryAug 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: ISHIYAMA Y, HIRANO Y, SASAKI M, AKUTA S, YOSHIZAWA M, YAMATO M, NAKANISHI A, MINAGAWA Y, HAYASHI H, FUJII T, OKAZAKI N, ISHII T, HIRANUMA C. END-TO-END ANASTOMOSIS WITH ECHELON ENDOPATH¿ STAPLE LINE REINFORCEMENT FOR RIGHT-SIDED COLON CANCER: SAFETY AND FEASIBILITY. IN VIVO. 2025 MAY-JUN;39(3):1573-1579. DOI: 10.21873/INVIVO.13957. PMID: 40294993; PMCID: PMC12041969. THE AIM OF THIS RETROSPECTIVE STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF FEEA WITH SLR COMPARED TO CONVENTIONAL FEEA IN ELECTIVE RIGHT-SIDED COLON CANCER SURGERY. BETWEEN FEBRUARY 2019 AND DECEMBER 2022, A TOTAL OF 159 (SURGICAL TECHNIQUE GROUP; 90 AND NON SURGICAL TECHNIQUE GROUP; 69) CONSECUTIVE PATIENTS WHO UNDERWENT ELECTIVE SURGERY FOR RIGHT-SIDED COLON CANCER. ECHELON FLEX (EES) WAS USED TO DISSECT AND ANASTOMOSED THE ILEUM AND COLON IN SURGICAL TECHNIQUE (SLR GROUP), WHILE IT WAS USED TO CLOSED THE COMMON HOLE IN NON-SLR. WHILE ECHELON ENDOPATH (EES) WAS USED TO CLOSED THE COMMON HOLE. REPORTED COMPLICATIONS: ECHELON FLEX (EES). ECHELON ENDOPATH (EES). SLR GROUP (N=90). NON SLR GROUP (N=69). SLR GROUP (N=90). POS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22797462 ↗
• MalfunctionAug 7, 2025Difficult to Open or Close; Difficult to Open or Close

  DURING AN UNK PROCEDURE, THE DEVICE CANNOT BE OPENED ANYMORE. NO PATIENT HARM WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22743184 ↗
• MalfunctionJul 14, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22500618 ↗
• MalfunctionJul 2, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385036 ↗
• MalfunctionJun 25, 2025Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event; Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE VIA LAPAROSCOPY, IT WAS OBSERVED THAT THE STAPLING WAS INCOMPLETE ALONG THE ENTIRE LENGTH, WITH TEARING OF THE STOMACH TISSUES. DURING THE LAST STAPLING, THE CLAMP GOT STUCK IN THE CLOSED POSITION, AND IT WAS VERY DIFFICULT TO OPEN IT. THERE WAS BLEEDING AND TEARING OF THE TISSUES AROUND THE STAPLING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 22331926 ↗
• MalfunctionJun 12, 2025Failure to Form Staple; Failure to Fire; Failure to Form Staple; Failure to Fire

  IT WAS REPORTED THAT DURING A BYPASS PROCEDURE, THE STAPLES ARE BEING DEPLOYED BUT DO NOT MAKE CONTACT WITH THE ANVIL, RESULTING IN MULTIPLE CASES WHERE THE STAPLE LINES CONTAIN GAPS. THIS HAS REQUIRED ADDITIONAL REINFORCEMENT OR OVERLAPPING STAPLING. THE STAPLER ITSELF FUNCTIONS WELL AND IS THOROUGHLY CLEANED BETWEEN USES. THIS ISSUE HAS ALSO OCCURRED ON THE VERY FIRST FIRING, RULING OUT THE POSSIBILITY OF A LEFTOVER STAPLE FROM A PREVIOUS USE. THE SURGERY WAS DELAYED BY 10 MINUTES. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197043 ↗
• MalfunctionJun 9, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22167757 ↗
• MalfunctionMay 28, 2025Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event; Failure to Fire; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A MORBID OBESITY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE LOCKED OUT. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096049 ↗
• MalfunctionMay 23, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE THEY WERE UNABLE TO TURN THE DEVICE PROPERLY. 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 22077946 ↗