Echelon Endopath GST60DRecalls & reported problems

Summary

The FDA's MAUDE database contains 450 adverse event reports that list this exact device (DI 10705036014690), received between Nov 29, 2017 and Sep 25, 2026 — classified as 1 death, 34 injuries, 415 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (198 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 450 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 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 50899548 ↗
• MalfunctionSep 25, 2026Failure to Form Staple

  It was reported that during an unspecified surgical 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 50898036 ↗
• MalfunctionSep 24, 2026Failure to Form Staple

  It was reported that during an unspecified surgical 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 50883315 ↗
• MalfunctionSep 21, 2026Failure to Fire; Difficult to Open or Close; Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846829 ↗
• MalfunctionSep 18, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829166 ↗
• MalfunctionSep 17, 2026Failure to Form Staple

  It was reported that during an unknown procedure, it was observed that some staples were malformed with irregular shape. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808380 ↗
• MalfunctionAug 24, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50410550 ↗
• InjuryAug 13, 2026Patient Device Interaction Problem

  It was reported via Journal Article: This complaint is from a literature source. The following literature cite has been reviewed:Title: Routine staple-line clip reinforcement during laparoscopic distal pancreatectomy does not reduce clinically relevant pancreatic fistula: a multicenter randomized clinical trialAuthors: Min Kyu Sunga, Dakyum Shinb, Jaewoo Kwonc, Sang Hyun Shind, Woohyung Leea, Ki Byung Songa, Jae Hoon Leea, Dae Wook Hwanga, Song Cheol Kima Citation: DOI: 10.1097/JS9.0000000000005534 (No PubMed Citation Available).This study aims to evaluate whether routine clip reinforcement reduces Clinically relevant postoperative pancreatic fistula (CR-POPF) incidence and whether its effect is influenced by pancreatic texture or friability. Between June 2021 and February 2025, a total of 190 adult patients undergoing elective laparoscopic distal pancreatectomy (LDP), using a linear stapler with a gold cartridge (GST60D; Ethicon)were randomized 1:1 to stapled transection with metallic clip reinforcement (clip group, n = 96) using metallic clips (LT200; Ethicon) or standard stapled transection alone (no-clip group, n = 94). Reported complications are:Clip Group and No-clip Group.

  Patient problems: Fistula

  MAUDE report 50234034 ↗
• MalfunctionAug 6, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50164753 ↗
• MalfunctionAug 4, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133033 ↗
• MalfunctionJul 27, 2026Material Integrity Problem; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020190 ↗
• MalfunctionJul 27, 2026Material Integrity Problem; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020189 ↗
• MalfunctionJul 27, 2026Material Integrity Problem; Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020188 ↗
• MalfunctionJun 9, 2026Difficult to Open or Close; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER THE CARTRIDGE WAS LOADED, AND THE NURSE SQUEEZED THE LEVER AND CLOSED THE TIP AS THE TEST, THE TIP DID NOT CLOSE. THERE WAS NOTHING TO DEAL WITH THIS, SO THE HOSPITAL FIRED THE DEVICE AND EXCHANGED THE CARTRIDGE, THE DEVICE COULD BE USED WITH NO PROBLEM. THE NURSE AND THE DOCTOR SEE THIS ISSUE THAT THIS DEFECT OCCURRED BECAUSE OF THE CARTRIDGE USED AT THE FIRST FIRING. THE CARTRIDGE COLOR WAS GOLD. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444846 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  I WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LEAK OCCURRED, AND THE COMMON DENOMINATOR WAS THE GOLD RELOAD. IF OTHER, DESCRIBE ANASTOMOTIC LEAKAGE, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, WAS DEVICE EXPLANTED? FALSE, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? REOPERATION, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? REOPERATION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IF YES, DESCRIBE REOPERATION.

  Patient problems: Failure to Anastomose

  MAUDE report 25233035 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  I WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE A LEAK OCCURRED, AND THE COMMON DENOMINATOR WAS THE GOLD RELOAD. IF OTHER, DESCRIBE: ANASTOMOTIC LEAKAGE. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? YES. DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES. WAS DEVICE EXPLANTED? FALSE. DID PATIENT REQUIRE REVISION SURGERY? TRUE IF NO, WAS THERE ANY ADDITIONAL MEDICAL INTERVENTION REQUIRED SUCH AS X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS? REOPERATION. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? REOPERATION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IF YES, DESCRIBE: REOPERATION.

  Patient problems: Failure to Anastomose

  MAUDE report 25233022 ↗
• MalfunctionMay 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DEVICE LOCKED OUT WITH A CARTRIDGE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25097822 ↗
• MalfunctionMay 5, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT FIRE FARTHER AFTER FIRED 1/3. 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 25086230 ↗
• MalfunctionApr 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A GASTRECTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 25028298 ↗
• MalfunctionApr 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A LOBECTOMY SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. 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 25028050 ↗
• MalfunctionApr 28, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ALLEGEDLY DEFECTIVE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020328 ↗
• MalfunctionApr 27, 2026Unintended Ejection

  IT WAS REPORTED THAT DURING AN UNSPECIFIED THORACIC PROCEDURE, IT WAS OBSERVED THAT THE RELOAD FELL OFF THE GUN JUST PRIOR TO STAPLING LUNG PARENCHYMA. THEY HEARD CLICK OF RELOAD BEING LOADED CORRECTLY PRIOR TO BEING PASSED UP TO SURGEON. CONTINUED WITH DEVICE FOR A FIRING AFTER AND WORKED WITHOUT ISSUE WITH A NEW RELOAD. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25004920 ↗
• MalfunctionApr 20, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL 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 24928122 ↗
• MalfunctionApr 15, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ALLEGEDLY DEFECTIVE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887372 ↗
• MalfunctionApr 15, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED ALLEGEDLY DEFECTIVE PRODUCTS. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887358 ↗