ECHELON GCS40GRecalls & reported problems

Summary

The FDA's MAUDE database contains 219 adverse event reports that list this exact device (DI 10705036027508), received between Jan 31, 2022 and Sep 30, 2026 — classified as 2 deaths, 28 injuries, 189 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (102 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 25 most recent of 219 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Fire

  It was reported that during a Pelvic mass cystourethroscopy the use of the device in the operating room, the following failure occurred:¿ When using the contour it failed, did not fire and disassembled.Was there any harm to the reported patient or user? No

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947229 ↗
• MalfunctionSep 29, 2026Failure to Fire

  It was reported that during a Rectosigmoidectomy that tissue was being cut without stapling, making it impossible to restart the reconstruction of intestinal transit.Was there any damage or injury reported by the patient or user? Unknown Was there a significant delay? Unknown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931620 ↗
• MalfunctionSep 22, 2026Difficult to Open or Close

  It was reported that during an Unknown procedure at the time of the mechanical suture shot Contour, safety pin locks locked and there is no opening of the pistol and they are loose wires in the reload. Was there any harm to the reported patient or user? No.Was there a significant delay? No.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852896 ↗
• MalfunctionAug 21, 2026Unintended Ejection

  It was reported that during an unknown procedure, the surgical team encountered a problem with the Contour GCS40G stapler, lot A99Z18, in which the cartridge was disengaged from the stapler¿s jaw, preventing completion of the surgical procedure. It was necessary to open a new device to continue. Was there any damage or loss reported by the patient or user? No.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50370210 ↗
• MalfunctionAug 14, 2026Material Integrity Problem

  It was reported that during an Unknown procedure the Stapler handle won't hold, pin keeps coming downAre there any reported cases of harm from patients or users? Unknown Was there a significant delay? Unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253133 ↗
• MalfunctionJul 7, 2026Insufficient Device Problem Information

  THE DEVICE WAS RECEIVED WITH NO EVENT DETAILS. ATTEMPTS WERE MADE TO OBTAIN DETAILS AND NO INFORMATION WAS PROVIDED. NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736994 ↗
• MalfunctionJul 7, 2026Difficult to Insert; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT LOADING CLOSING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736610 ↗
• InjuryJul 7, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, AFTER STAPLING THE DISTAL RECTUM WITH CONTOUR STAPLER, I PROCEEDED TO ANASTOMOSIS STRAIGHT LAP WITH CIRCULAR STAPLER, BUT WHEN INSERTING AND LOCATING THE CIRCULAR STAPLER, THERE WAS A TOTAL OPENING OF CONTOUR STAPLES, REQUIRING THE MANUAL CLOSURE OF THE DISTAL RECTUM. THEN WE PROCEEDED RECTAL ANASTOMOSIS WITH CIRCULAR STAPLER WHICH WAS NOT SATISFACTORY, AND IT WAS NECESSARY TO PERFORM PROTECTIVE COLOSTOMY.

  Patient problems: Wound Dehiscence

  MAUDE report 25736390 ↗
• MalfunctionJul 7, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STAPLER FAILED, DID NOT RELEASE THE STAPLES. WAS THERE ANY DAMAGE OR LOSS REPORTED BY THE PATIENT OR USER? NO. WAS THERE A SIGNIFICANT DELAY? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25733255 ↗
• MalfunctionJun 18, 2026Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, AFTER THE FIRST FIRING THE DEVICE WOULD NOT RELEASE. THIS IS FOR AN ECHELON CURVED CONTOUR STAPLER. THERE IS NO ADVERSE IMPACT ON PATIENT/USER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25547294 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, STAPLES DID NOT CLOSE DURING THE PROCESS. THERE WAS NO DELAY IN THE PROCEDURE AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25334763 ↗
• MalfunctionMay 26, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, IN EMERGENCY SURGERY, IT GETS STUCK AND COMES LOOSE. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280834 ↗
• MalfunctionMay 15, 2026Failure to Form Staple; Failure to Cut; Failure to Fire

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, OPENING OF THE STAPLE LINE OF THE RECTUS MUSCLE AFTER FIRING. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184899 ↗
• InjuryApr 23, 2026Failure to Form Staple; Noise, Audible

  IT WAS REPORTED THAT DURING A LAR THE UPON CLAMPING THE SPECIMEN, THERE WAS A VERY LOUD CRUNCH FROM THE STAPLER. LOUDER THAN USUAL. SUBSEQUENTLY ON FIRING, IT GOT STUCK. THEN SURGEON HAD TO RELEASE THE STAPLER, REAPPLY THEN REFIRE BUT STAPLE LINE WAS MESSED UP. IT WAS A STAPLER FROM MAKNA APPLICATION. PATIENT IS OK AND THE TEAM MANAGED TO SETTLE THE CASE WITH A DIFFERENT TECHNIQUE. THE PATIENT IS STILL UNDER OBSERVATION FOR POTENTIAL LEAK. SURGEON WILL FEEDBACK ON THE CONDITION SOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24967145 ↗
• MalfunctionApr 14, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, WHEN OPENED, THE ITEM WAS BROKEN. IT WAS NOT USED AND A REPLACEMENT ITEM WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873630 ↗
• MalfunctionApr 13, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CONTOUR STAPLED PARTIALLY RECTAL AND DISTAL STRAIGHT STUMP. THERE WAS NO IMPACT ON THE PATIENT, BUT HE HAD TO DISCARD THE PRODUCT BECAUSE IT WAS CONTAMINATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24865263 ↗
• MalfunctionApr 2, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, GCS40G WAS DAMAGED, UNUSABLE AND NO LONGER STERILE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769183 ↗
• MalfunctionApr 2, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, GCS40G WAS DAMAGED, UNUSABLE AND NO LONGER STERILE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769176 ↗
• MalfunctionApr 2, 2026Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, GCS40G WAS DAMAGED, UNUSABLE AND NO LONGER STERILE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769162 ↗
• MalfunctionMar 31, 2026Failure to Fire

  IT WAS REPORTED THAT DURING EXPLORATORY LAPAROTOMY SIGMOIDECTOMY PROCEDURE THE DEVICE WAS USED ONCE, AND WHEN A RELOAD IS PLACED, THE STAPLER ENGAGES WITH THE LOAD, BUT IT DOES NOT ALLOW YOU TO FIRE IT OR ENGAGE THE HANDLE. THERE WERE NO PATIENT ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747745 ↗
• MalfunctionMar 31, 2026Unintended Ejection

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE STAPLE RETAINER WAS LOOSER THAN USUAL AND SOON CAME OFF. THERE IS DEFECTIVE-JUDGED STAPLE RETAINER AND REPLACED STAPLE RETAINER CONTAIN BECAUSE THE NURSE SAID THAT THESE TWO HAVE ACCIDENTALLY MIXED. THE CARTRIDGE COLOR WAS GREEN. 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 24747432 ↗
• MalfunctionMar 30, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SURGEON MENTIONED THAT THE CONTOUR DEVICE FIRED BUT STAPLES WEREN'T PRESENT ALL THE WAY FROM ONE END TO THE OTHER. THERE WAS NO HARM TO THE PATIENTS AS THEY USED THE DEVICE FOR A HIGHER TRANSECTION SO THEY OVER SUTURED AND A NEW DEVICE WAS OPENED FOR THE DISTAL DIVISION OF THE BOWEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24737767 ↗
• MalfunctionMar 25, 2026Difficult to Open or Close

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE CLOSURE TRIGGER DID NOT CLOSE. A REPLACEMENT WAS TAKEN OUT, BUT IT DID NOT CLOSE EITHER, SO ANOTHER ONE WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. TWO DEVICES WILL BE RETURNING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690682 ↗
• MalfunctionMar 18, 2026Failure to Fire

  IT WAS REPORTED THAT THE DEVICE WAS USED IN A LAR. THE STAPLER FIRED INCOMPLETELY, RESULTING IN CUTTING WITHOUT STAPLING. THE PROCEDURE HAD TO BE COMPLETED WITH MANUAL SUTURING. THERE WAS SIGNIFICANT DELAY. NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24632128 ↗
• MalfunctionMar 3, 2026Unintended Ejection

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE, WHEN REMOVED THE RED RETAINING COVER AFTER OPENING THE PACKAGE, THE CARTRIDGE WAS NOT ATTACHED AND CAME OFF. IT SEEMS THAT IT WAS PROBABLY DUE TO POOR ADHESION. 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 24502141 ↗