N/A ECS29BRecalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 10705036022930), received between Apr 14, 2021 and Apr 6, 2026 — classified as 54 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (33 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 117 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Failure to Form Staple

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, PATIENT RETURNED TO SURGERY FOR REPAIR OF CECAL PERFORATION. PHYSICIAN STATED THE STAPLER HAD A LIGASURE MALFUNCTION.

  Patient problems: Perforation

  MAUDE report 24793058 ↗
• InjuryApr 6, 2026Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, PATIENT RETURNED TO SURGERY FOR REPAIR OF CECAL PERFORATION. PHYSICIAN STATED THE STAPLER HAD A LIGASURE MALFUNCTION.

  Patient problems: Perforation

  MAUDE report 24793024 ↗
• MalfunctionApr 2, 2026Failure to Form Staple; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, WHEN THE STAPLER WAS FIRED, THERE WAS A PARTIAL MISFIRE WERE AT LEAST ONE OR TWO STAPLES DID NOT FULLY CLOSE. AND ONE STAYED STUCK IN THE STAPLER WHICH THEY DIDN'T KNOW AND CAUSED A TEAR ON THE PATIENT'S TISSUE. THE KNIFE WAS ABLE TO CUT. AND THERE WERE NO PATIENT CONSEQUENCES.

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

  MAUDE report 24770071 ↗
• InjuryMar 31, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A LOW COLOSTOMY CLOSURE, THE EEA STAPLER WAS CONNECTED AND FIRED, BUT THE STAPLER CUT AND NO STAPLES WERE DEPLOYED. NO STAPLES WERE VISIBLE ANYWHERE IN THE TISSUE, EITHER PROXIMAL OR DISTALLY. THE ENTIRE ANVIL WAS IMMEDIATELY VISIBLE AFTER FIRING, CONSISTENT WITH THE STAPLER CUTTING WITHOUT STAPLES DEPLOYING. AT THIS POINT, FURTHER DISSECTION WOULD INCREASE RISK OF PELVIC NERVE INJURY AND MAY REQUIRE A COLOANAL ANASTOMOSIS. IT WAS DECIDED THIS WOULD BE BEST MANAGED BY A COLORECTAL SPECIALIST, SO ELECTED TO ABORT COLOSTOMY REVERSAL AND BRING UP A COLOSTOMY AGAIN. EEA STAPLER WAS POSITIONED IN THE RECTUM, ANVIL OPENED AND MATED TO THE COLON APPROPRIATELY. STAPLER CLOSED WITH MARKER IN GREEN ZONE. SAFETY REMOVED. STAPLER FIRED ONCE WITH LEVER TO THE STAPLER BODY. NO CRUNCH FELT OR HEARD, ONLY A CLICK. THE STAPLER WAS OPENED WITH TWO CUTS ENDS WITH NO STAPLES. NO STAPLES SEEN IN THE DEVICE EITHER.

  Patient problems: Insufficient Information

  MAUDE report 24746878 ↗
• MalfunctionJan 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE BATTERY WAS DRAINED BEFORE USING IT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100556 ↗
• MalfunctionDec 18, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE ECS CIRCULAR STAPLER DID NOT FIRE. THE STAPLER WAS REPLACED. THE PROCEDURE WAS DELAYED BY 2 MINUTES AND COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843096 ↗
• MalfunctionDec 12, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A ROBOTIC COLOSTOMY REVERSAL, THE STAPLER WAS USED IN AN END TO SIDE ANASTOMOSIS. DURING THE PROCEDURE, THEY WERE UNABLE TO REMOVE THE CIRCULAR STAPLER (ECS29B). THEY OPENED THE STAPLER PRIOR TO REMOVAL 2 FULL TURNS. THEY ROTATED THE STAPLER SIDE TO SIDE REPEATEDLY. AFTER THAT DID NOT WORK, THEY OPENED THE STAPLER AN ADDITIONAL FULL TURN. WHEN ATTEMPTING TO REMOVE IT THE ANVIL RELEASED FROM THE TROCAR AND REMAINED IN THE PATIENT. THEY PULLED THE STAPLER OUT AND USED A FLEXIBLE SIGMOIDOSCOPE. UPON VISUALIZATION THEY USED THE SNARE ON THE SCOPE TO RETRIEVE THE ANVIL. STAPLE LINES WERE EXAMINED AND A SUCCESSFUL LEAK TEST WAS PERFORMED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23792862 ↗
• MalfunctionAug 29, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A COLORECTAL PROCEDURE, WHEN FIRING ALL STAPLES, THE DEVICE CUT BUT DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE. NO PATIENT ISSUES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22921020 ↗
• MalfunctionAug 11, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS NO ROTATION WHEN EXTRACTING THE PLIERS AFTER STAPLING. RISK OF DAMAGE TO THE ANASTOMOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770435 ↗
• MalfunctionJul 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED DURING AN UNKNOWN PROCEDURE THAT THE STAPLE DID NOT FIRE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553606 ↗
• MalfunctionJul 21, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT PRODUCT DESCRIPTION IS 29 MM ETHICON CIRCULAR STAPLER XL SEALED. THE STAPLER DID NOT FIRE. THERE IS NO ADVERSE IMPACT PATIENT/USER WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553532 ↗
• MalfunctionJun 24, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE DID NOT CUT. NO PATIENT CONSEQUENCES REPORTED WHEN THIS COMPLAINT EVENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22318448 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING INTESTINAL RECHANALISATION SURGERY, A TERMINO-LATERAL MECHANICAL TRANS-ANAL COLORECTAL ANASTOMOSIS IS PACKAGED. FREE OF TENSION WITH CIRCULAR MECHANICAL STAPLER. BOTH SUTURE RINGS APPEAR UNDAMAGED. THEN THERE IS A LARGE DEHISCENCE OF THE ANTERIOR WALL WITH THE LEAKAGE OF FECAL MATERIAL. NEED TO REMOVE ANASTOMOSIS AND PACK A NEW LATERO-TERMINAL ANASTOMOSIS WITH ANOTHER STAPLER. IN VIEW OF PELVIC CONTAMINATION AND TISSUE FRAGILITY, IT IS CONSIDERED APPROPRIATE TO PROTECT ANASTOMOSIS BY ILEOSTOMY.

  Patient problems: Failure to Anastomose

  MAUDE report 22104640 ↗
• MalfunctionDec 9, 2024Failure to Cut; Ejection Problem; Failure to Cut; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE MISFIRED. THE ANVIL OF THE GUN WAS STUCK IN THE BOWEL WHICH THEN HAD TO BE SEPARATED FROM THE GUN TO BE REMOVED. USED A NEW GUN AND WORKED FINE. THE GUN WAS FIRED FULLY. THEREFORE THE KNIFE DID NOT CUT THOUGHT BOTH SIDES OF ANASTOMOSIS. THIS WAS EVIDENT AS TO WHY THE ANVIL COULD NOT BE REMOVED AND THERE WAS ONLY ONE RING IN THE GUN ONCE REMOVED. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT AS THEY REDID THE ANASTOMOSIS AND THE SECOND GUN FIRED AND WORKED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878527 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP TO A LOW ANTERIOR RESECTION THE SURGEON HAD TO BRING A PATIENT BACK TO ADDRESS THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20852354 ↗
• MalfunctionNov 11, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE FORCEPS FAILED TO ENGAGE, MAKING RECTO-COLONIC ANASTOMOSIS IMPOSSIBLE. THE FORCEPS HAD TO BE REMOVED WITHOUT THE ANVIL, WHICH REMAINED IN PLACE ON THE COLON. SUBSEQUENTLY, THE RECTAL STUMP WAS RE-CUT, WITH A CHANGE OF FORCEPS (HAVING THE SAME LOT AND NO DIFFICULTY IN MAKING THE ANASTOMOSIS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651775 ↗
• InjuryOct 11, 2024Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Failure to Eject; Failure to Fire; Difficult to Open or Close; Adverse Event Without Identified Device or Use Problem; Failure to Eject

  IT WAS REPORTED THAT THE SURGEON WAS USING THE ECS29B FOR A COLORECTAL ANASTOMOSIS. THE SURGEON HAD PLACED THE ANVIL AND ATTACHED THE HEAD TO THE STAPLER. WHEN HE WENT TO CLOSE THE STAPLER BEFORE FIRING, THE KNOB WOULD TWIST BUT WAS ¿SLIPPING¿ AND THE DEVICE WOULD NOT CLOSE. IT WAS TOLD THE DEVICE WAS UNABLE TO FIRE AND THE SURGEON HAS TO CUT MORE BOWEL OUT OF THE PATIENT TO REMOVE THE DEVICE. THEY OPENED ANOTHER OF THE SAME STAPLER TO COMPLETE THE CASE AND IT WORKED FINE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 20433135 ↗
• MalfunctionOct 2, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR RESECTION THE ANVIL WAS DIFFICULT TO REMOVE FROM TROCAR DURING SETUP. ANVIL ALSO VERY DIFFICULT TO PLACE ON TROCAR INTRAOPERATIVELY AND REMOVE TO CHECK DONUTS ONCE FIRED. THE SURGERY WAS DELAYED 5 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20352439 ↗
• MalfunctionOct 2, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A LAP BOWEL RESECTION THEY FIRED THE CIRCULAR STAPLER TO DO THE ANASTOMOSIS ON HIS HAND-ASSISTED LAP SIGMOID COLECTOMY W/ILEOSTOMY. AFTER FIRING, IT WAS NOTED THE "STAPLER DIDN'T SEAL THE COLON". NO STAPLES, FORMED OR UNFORMED, WERE SEEN AFTER THE FIRING AS WELL. THEY THEN OPENED A SECOND CIRCULAR STAPLER TO COMPLETE THE CASE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES AND NO CHANGES TO THE POST-OPERATIVE CARE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20351410 ↗
• InjurySep 18, 2024Difficult to Open or Close; Ejection Problem; Difficult to Open or Close; Ejection Problem

  IT WAS REPORTED DURING A HARTMANN RESECTION DURING FIRING OF STAPLER NO CLICK FROM CUTTING THROUGH BREAK AWAY WASHER. HARD TO CLOSE DEVICE AND HARD TO REMOVE. THERE WAS 1 HOUR OF ADDITIONAL SURGERY TIME. USE OF A PROCTOSCOPY TO REMOVE ANVIL.

  Patient problems: Insufficient Information

  MAUDE report 20249133 ↗
• MalfunctionSep 10, 2024Failure to Fire; Ejection Problem; Failure to Fire; Ejection Problem

  IT WAS REPORTED THAT DURING A ROBOTIC SURGERY THERE WAS AN ISSUE IN REMOVING THE STAPLER (AFTER CLIPS SHOOTING AND TIP OPENING). THE MUCOSA REMAINED STUCK IN THE STAPLER AND IN SOME AREA THE ANASTOMOSIS REMAINED OPEN. THE SURGERY HAS BEEN ENDED APPLYING A MANUAL ANASTOMOSIS AS REINFORCEMENT THE SURGERY WAS DELAYED. MANUAL ANASTOMOSIS AS REINFORCEMENT , THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20179917 ↗
• MalfunctionSep 4, 2024Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING AN UNKNOWN LEFT COLON PROCEDURE THAT ABOUT ONE FORTH OF THE STAPLES ON THE OUTER RIM APPEARED TO BE UNFORMED. LEAK TEST WAS PREFORMED AND NO LEAKS WERE DETECTED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20133958 ↗
• MalfunctionAug 20, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE HANDLE WOULD NOT CLAMP INTO THE STAPLER. THERE WERE NO PATIENT CONSEQUENCES REPORTED. UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007059 ↗
• MalfunctionAug 14, 2024Failure to Fire; Ejection Problem; Failure to Fire; Ejection Problem

  IT WAS REPORTED THAT DURING A COLON RESECTION THEY HAD SOME ISSUE IN REMOVING THE STAPLER ( AFTER CLIPS SHOOTING AND TIP OPENING). THE MUCOSA REMAINED STUCK IN THE STAPLER AND IN SOME AREA THE ANASTOMOSIS REMAINED OPEN. THE SURGERY HAS BEEN ENDED APPLYING A MANUAL ANASTOMOSIS AS REINFORCEMENT. THERE WAS A SURGICAL DELAY IN THE PROCEDURE THE EXACT TIME IS UNK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981142 ↗
• InjuryAug 13, 2024Failure to Fire; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAP ANTERIOR RESECTION THE PROCEDURE WENT WELL, UNTIL CIRCULAR STAPLE GUN (ACS 29) WAS FIRED AFTER INTRODUCING IT THROUGH RECTUM. THE GUN SHOULD FIRE STAPLES AND THEN CUT IN BETWEEN. THE GUN FIRED AS USUAL, DOUGHNUTS WERE COMPLETE. SUBSEQUENT AIR LEAK TEST SHOWED A LARGE LEAK. SUBSEQUENT INSPECTION SHOWED THAT THERE WERE NO STAPLES FIRED, BEFORE CUTTING THE BOWEL ENDS. HENCE, PATIENT HAD TO HAVE A HARTMANN'S PROCEDURE- LONG TERM COLOSTOMY. WE INTRODUCED THE GUN IN THE USUAL MANNER, WITH THE TIP PERFORATING THE RECTAL STUMP AND THEN ENGAGED THE ANVIL. THEN WE CLOSED THE GUN AND FIRED THE GUN IN USUAL MANNER. WITHDREW THE GUN- DOUGHNUTS WERE COMPLETE. AIR TEST- LARGE LEAK. ON INSPECTION, NO STAPLES NOTED ON BOWEL OR ON THE GUN.

  Patient problems: Failure to Anastomose

  MAUDE report 19974737 ↗