ECHELON GCS40BRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10705036027515), received between Apr 1, 2022 and Aug 27, 2026 — classified as 3 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (20 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Structural Problem; Failure to Fire

  It was reported that, during an unknown surgery, the knife was loose and did not move even after removing the red lid. The device did not activate even the retainer was removed. The cartridge color was Blue. 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 50476442 ↗
• MalfunctionAug 13, 2026Failure to Fire

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236554 ↗
• MalfunctionAug 4, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50128575 ↗
• MalfunctionJun 29, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN THE SURGEON WAS TRYING TO ALIGN THE DEVICE WITH THE RECTUM, THE STAPLER FIRED WITHOUT THE SURGEON ACTIVATING THE FIRING HANDLE. NO PATIENT CONSEQUENCE WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25651147 ↗
• MalfunctionMar 31, 2026Failure to Fire

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE DEVICE COULD NOT BE FIRED WHEN TRYING TO FIRE. 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 24746227 ↗
• MalfunctionFeb 26, 2026Failure to Fire

  IT WAS REPORTED THAT THE STAPLER WAS FIRED WITH THE LOAD THAT IT CAME WITH. THEY RELOADED THE STAPLER WITH THE RELOAD STAPLES AND IT ONLY FIRED HALF THE STAPLES. NO ADVERSE IMPACT PATIENT/USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24455395 ↗
• MalfunctionJan 7, 2026

  ETHICON CONTOUR CURVED CUTTER TRIGGER JAMMED. JAWS WOULD NOT CLOSE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990549 ↗
• MalfunctionJan 6, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE WOULD NOT FIRE. SURGICAL DELAY WAS UNKNOWN. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973748 ↗
• MalfunctionOct 22, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A SIGMOID COLON PROCEDURE, WHEN ATTEMPTING TO FIRE THE STAPLER, THE BOTTOM ROW HAD VISIBLE HOLES AND WAS LEAKING. THE PATIENT WAS FINE AND THE LEAK WAS REPAIRED. A NEW DEVICE WAS OPENED AND WORKED PROPERLY.

  Patient problems: Failure to Anastomose; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356822 ↗
• MalfunctionOct 6, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CONTOUR MISFIRED, IT CUT WITHOUT STAPLING. THE CUSTOMER BELIEVES THAT THERE WERE NO STAPLES IN THE DEVICE. THEY HAD TO REMOVE THE DEVICE AND HAND SEW THE ANASTOMOSIS. OPENED ANOTHER DEVICE. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE EXTENDED GREATER THAN 30 MINUTES DUE TO THE FAILURE? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23221036 ↗
• MalfunctionAug 11, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT CLOSE PROPERLY DURING THE CASE. THEY HAD TO USE A DIFFERENT DEVICE TO FINISH THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771328 ↗
• MalfunctionAug 7, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A THORACOSCOPIC ESOPHAGECTOMY, GCS40B WAS USED FOR THE GASTRIC TUBE ANGIOPLASTY. WHEN TAKING OUT THE PRODUCT FROM THE PACKAGE BEFORE USE, THE PUSH ROD HAD ALREADY COME OFF. THE DOCTOR WAS CONCERNED ABOUT A MISS-FIRING, SO THE DEVICE WAS REFRAINED FROM USING, AND A NEW GCS40B WAS TAKEN OUT AND USED INSTEAD. 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 22740529 ↗
• MalfunctionApr 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A ROBOT ASSISTED GASTRIC TUBE PROCEDURE, IT WAS FOUND THAT IT WAS STIFF AND DIFFICULT TO MOVE WHEN THE SCRUB NURSE CHECKED FOR OPERATION. THE DEVICE COULD NOT BE FIRED WHEN THE DOCTOR USED THE DEVICE AND FOUND IT TOO HARD TO GRIP. 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 21873150 ↗
• MalfunctionMar 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SIGMOID RESECTION, WHILE USING THE DEVICE, THERE WERE NO STAPLES DEPLOYED AFTER PULLING THE TRIGGER. THE TISSUE WAS TRANSECTED. NO STAPLES IN THE PROXIMAL OR DISTAL SIDE. CASE WAS COMPLETED BY HAND SUTURING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632687 ↗
• MalfunctionJan 29, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CONTOUR WAS USED TO TRANSECT THE RECTUM, PROTOCOL WAS FOLLOWED AND THE STAPLER SEEMED TO HAVE FIRED PROPERLY. AFTER FIRING, THE STAPLE LINE LOOKED OKAY BUT ONCE THE END TO END ANASTOMOSIS HAD BEEN CREATED, THE CONTOUR STAPLE LINE RELEASED. THE SURGEON NOTED THAT THE MUCOSA WAS VISIBLE AND THAT THE STAPLES WERE NOT COMPLETELY FORMED. THE ANASTOMOSES HAD TO BE REDONE BY HAND SEWING. THE SURGERY WAS DELAYED 60 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263281 ↗
• MalfunctionJan 28, 2025Difficult to Insert; Failure to Cut; Difficult to Open or Close; Firing Problem; Difficult to Insert; Failure to Cut; Difficult to Open or Close; Firing Problem

  IT WAS REPORTED THAT DURING A LEFT HEMI-COLECTOMY BY LAPAROTOMY AFTER THE FIRST STAPLING, IT WAS DIFFICULT TO REMOVE THE FIRST STAPLE ROW (ALREADY RELOADED ON THE DEVICE INSIDE THE BLISTER). RELOADING OF A NEW STAPLE RELOAD: IT WAS IMPOSSIBLE TO CLOSE THE DEVICE AND CUT. THE COLIC CUT WAS PERFORMED MANUALLY WITH A COLD BLADE. NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21255185 ↗
• MalfunctionJan 24, 2025Difficult to Insert; Failure to Fire; Difficult to Insert; Failure to Fire

  IT WAS REPORTED THAT DURING A COLON RESECTION THE DEVICE WOULD NOT FIRE OUT THE RELOADS. THE PROCEDURE WAS DELAYED BY FIVE MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21228813 ↗
• MalfunctionJan 22, 2025Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event; Failure to Form Staple; Difficult to Open or Close; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC TUBE ANGIOPLASTY FOR ESOPHAGEAL CANCER, THE RELEASE BUTTON COULD NOT PRESS AND THE JAWS COULD OPEN AFTER FIRING, SO THE GRASPED TISSUE WAS PULLED OUT THROUGH THE GAP. THE STAPLES WERE MALFORMED. IT WAS USED ON GASTRIC BODY. ADDITIONAL HAND SUTURE WAS PERFORMED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 21207598 ↗
• InjuryDec 10, 2024Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  PER USER FACILITY MEDWATCH FORM, #MW5162355, PARTIAL COLECTOMY PERFORMED ON 2024. THREE STAPLE CONTOUR LOADS WERE USED. PATIENT LEFT IN DISCONTINUITY WITH ABTHERA VAC WITH PLAN TO RETURN TO GENERAL OPERATING ROOM ON 2024 FOR CREATION OF OSTOMY. UPON RE-ENTRY TO THE ABDOMEN (AS PLANNED) THE STAPLE LINE ON THE PROXIMAL SIGMOID COLON WAS WIDE OPEN WITH STOOL LEAKING INTO THE PELVIS. ALL STAPLES THAT WERE FOUND IN THE SIGMOID APPEARED TO HAVE BEEN IN THE TISSUE, BUT THE ENDS WERE NOT BENT OR CURLED LIKE THEY ARE NORMALLY, SO THE PROXIMAL COLON WAS WIDE OPEN.

  Patient problems: Failure to Anastomose

  MAUDE report 20891398 ↗
• MalfunctionNov 7, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE CARTRIDGE DID NOT FIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629980 ↗
• MalfunctionSep 5, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE PIN BECAME LOCKED DURING FIRING AND BECAME UNUSABLE DUE TO PIN BEING UNABLE TO BE RELEASED. CASE WAS COMPLETED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20152199 ↗
• MalfunctionSep 4, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A COLON RESECTION A CONTOUR BLUE STAPLER WAS USED TO TRANSECT THE COLON. ONCE FIRED THE SURGEON NOTED THAT THE STAPLER HAD CUT, BUT NO STAPLES HAD DEPLOYED. A NEW STAPLER WAS OPENED AND THE CASE WAS COMPLETED SUCCESSFULLY. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20134962 ↗
• MalfunctionJun 22, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE THE INSTRUMENT COULD NO LONGER BE CLOSED OR FIRED AFTER INITIAL CLOSING AND REPOSITIONING ON THE TISSUE. NO PATIENT HARM NOR SIGNIFICANT DELAY REPORTED. PROCEDURE FINISHED SUCCESSFULLY WITH SAME LIKE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19590925 ↗
• InjuryMay 13, 2024Failure to Cut; Material Integrity Problem; Failure to Cut; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE SURGEON HAD ISSUES WITH A CONTOUR STAPLER AND RELOAD. THE TECH STATED WHEN HE WENT TO LOAD THE STAPLER, HE WAS USING THE RELOAD WITH THE CLEAR PLASTIC PIECE ON THE END. IT WAS NOT THE UPDATED RELOAD WITH THE YELLOW PLASTIC PIECE. HE STATED THAT HE REMOVED THE RED SAFETY FROM THE RELOAD FIRST AND THEN LOADED THE STAPLER WITH THE RELOAD. HE SAID WHEN HE WAS LOADING THE STAPLER THAT THE CLEAR PLASTIC PIECE CAME OFF OF THE RELOAD WHICH IS HOW HE THOUGHT THE DEVICE WORKED. WHEN THE SURGEON FIRED THE STAPLER, THE STAPLER DEPLOYED STAPLES, HOWEVER THE DEVICE DID NOT CUT. THE STAFF OPENED UP ANOTHER LIKE DEVICE AND RELOAD AND HAD TO FIRE THE SECOND DEVICE BELOW THE CURRENT STAPLE LINE. THE STAFF STATED THAT WHEN THE SURGEON WENT TO SIZE THE PATIENT WITH THE SIZERS, THAT THE SURGEON WENT THROUGH THE BOWEL AND THE PATIENT ENDED UP HAVING TO HAVE A COLOSTOMY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19305463 ↗
• MalfunctionApr 23, 2024Difficult to Open or Close; Material Integrity Problem; Difficult to Open or Close; Material Integrity Problem

  IT WAS REPORTED THAT DURING A COLOSTOMY PROCEDURE THE CONTOUR RETAINING PIN WASN'T GOING FORWARD WHERE THE DEVICE COULDN'T CLOSE/BE USED. THEY GOT ANOTHER DEVICE TO COMPLETE THE COLOSTOMY WITHOUT PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19169079 ↗