N/A ECS25BRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10705036022923), received between Jul 14, 2021 and Jun 16, 2026 — classified as 10 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Failure to Fire” (12 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Failure to Fire

  IT WAS REPORTED THAT DURING A PERFORMED A RECANALIZATION OPERATION (HARTMANN II CENTURY), PERFORMED A LATEROTERMINAL ANASTOMOSIS BETWEEN THE COLON AND RECTUM WITH AN ECS25B STAPLER, TO THE VISUAL CONTROL OF THE ANASTOMOSIS, THIS WAS INCOMPLETE. THE ANASTOMOTIC RINGS WERE INTACT. THE SURGEON SUTURED THE PART OF THE ANASTOMOSIS WITHOUT STAPLES BY HAND. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524064 ↗
• MalfunctionFeb 27, 2026Failure to Fire

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE DID NOT WORK, WHEN TRYING TO FIRING. THEREFORE, USED ANOTHER DEVICE. NO FURTHER DETAILS WERE PROVIDED. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474718 ↗
• MalfunctionJun 10, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE ANVIL COULD NOT BE REMOVED FROM THE MAIN BODY. THERE WAS NO EFFECT ON THE PATIENT. 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 22175216 ↗
• InjuryMar 31, 2025Failure to Fire; Firing Problem; Failure to Fire; Firing Problem

  IT WAS REPORTED THAT DURING A COLON RESECTION PROCEDURE THAT THE DEVICE DID NOT FIRE. NO FURTHER INFORMATION WAS PROVIDED TO THE REP. THE PATIENT ENDED WITH AN UNPLANNED COLOSTOMY.

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

  MAUDE report 21730817 ↗
• InjuryMar 3, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: NEW PURSE-STRING SUTURE CLAMP AND MULTI-FUNCTIONAL SEAL CAP: A SIMPLE INTRACORPOREAL CIRCULAR-STAPLED OESOPHAGOJEJUNOSTOMY AFTER LAPAROSCOPIC TOTAL GASTRECTOMY AUTHORS: JIANJUN DU, JUNJIE LIU, LIZHI ZHAO, HAOHAI JIANG, ZIQIANG ZHANG, CITATION: LANGENBECK'S ARCHIVES OF SURGERY (2025) 410:9. HTTPS://DOI.ORG/10.1007/S00423-024-03571-X. THE AIM OF THIS STUDY WAS TO EVALUATE AND ANALYZE THE SURGICAL DETAILS AND POSTOPERATIVE OUTCOMES OF THIS "LAP-PSC WITH MSC TECHNIQUE". BETWEEN MAY 2023 AND OCTOBER 2023, A NEW LAPAROSCOPIC PURSE-STRING SUTURE CLAMP (LAP-PSC) AND MULTI-FUNCTIONAL SEAL CAP (MSC) WERE APPLIED TO OBTAIN A SIMPLE INTRACORPOREAL CIRCULAR-STAPLED OESOPHAGOJEJUNOSTOMY AFTER LAPAROSCOPIC TOTAL GASTRECTOMY IN 21 PATIENTS (16 MALE AND 5 FEMALES; MEAN AGE OF 63.6±9.2 YEARS) WITH GASTRIC CANCER IN THE AUTHORS' HOSPITAL. A 25-MM ANVIL TIED WITH A 2-0 THREAD (BRAIDED NYLON, SURGILON; MEDTRONIC, MINNEAPOLIS, MN) ON THE TIP OF THE ANVIL CENTRAL ROD (ETHICON¿ CIRCULAR STAPLER; ECS25B; ETHICON ENDO-SURGERY, CINCINNATI, OH) WAS PLACED INTO THE ABDOMINAL CAVITY THROUGH A SEPARATE 3-CM INCISION ON THE LEFT MIDDLE CLAVICULAR LINE ABOVE THE LEVEL OF

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 21504212 ↗
• MalfunctionFeb 24, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS THE CIRCULAR STAPLER DIDN'T FULLY CLOSE. THE SURGEON HAS ONLY NOTICED AFTER FIRING. THE SURGEON OVERSEWED THE STAPLE LINE, AS HE COULDN'T EVALUATE WHETHER THE STAPLES HAD FORMED AS THEY SHOULD. TEST WITH BLUE CONTRAST FLUID WAS OK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21448198 ↗
• MalfunctionJan 3, 2025

  STAPLER WAS BEING USED FOR SURGICAL PROCEDURE AND WAS NOT FUNCTIONING PROPERLY. STAPLER WOULD NOT FIRE AND DEPLOY A STAPLE. THE DEVICE WAS NOT ABLE TO COMPLETE ITS INTENDED TASK. STAPLER WAS REMOVED FROM THE FIELD AND A NEW STAPLER WAS USED SUCCESSFULLY. THE MALFUNCTIONING STAPLER WAS PULLED AS A PEEL PACK (REF #ECS25B, LOT #C9EN6F).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066660 ↗
• MalfunctionDec 12, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THAT STAPLER WAS USED FOR SURGICAL PROCEDURE AND WAS NOT FUNCTIONING PROPERLY. STAPLER DID NOT FIRE AND WAS NOT ABLE TO COMPLETE ITS INTENDED TASK. STAPLER WAS PULLED AS A PEEL PACK. PATIENT CONSEQUENCES UNKNOWN. PROCEDURE WAS DELAYED DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913926 ↗
• InjurySep 5, 2024Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A ROBOTIC ESOPHAGECTOMY PROCEDURE THAT WHEN THE FELLOW WENT TO FIRE THE FIRST STAPLER SHE DIDN'T HEAR THE "CRUNCH" WHEN THE DEVICE WAS OPENED IT WAS FOUND THE DEVICE CUT BUT DID NOT STAPLE. PROCEDURE WAS CONVERTED TO OPEN. THE STAPLE LINE WAS THEN OVER SEWED. PATIENT CURRENTLY DOING OK.

  Patient problems: Insufficient Information

  MAUDE report 20146095 ↗
• MalfunctionMay 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A COLECTOMY THE DEVICE WAS FIRED, THEY SAID IT FELT WEIRD AND FELT IT DIDN'T TRANSECT PROPERLY. NO PATIENT HARM REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359670 ↗
• MalfunctionMay 17, 2024Failure to Form Staple; Firing Problem; Failure to Form Staple; Firing Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS WITH SURGEON, WHEN FA ATTEMPTED TO USE DEVICE UPON ACTIVATING DEVICE, THAT DID NOT SOUND/FEEL RIGHT. HE COMPLETED THE PROCESS, IT CUT AND MADE THE ANASTOMOTIC RINGS, HOWEVER IT DID NOT SEAL. OPENED SECOND DEVICE AND USED COMPLETED PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19340067 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. CLINICAL AND ECONOMIC OUTCOMES OF ADVANCED ENERGY DEVICES IN BREAST CANCER SURGERY: A RETROSPECTIVE ANALYSIS. ETHICON CIRCULAR STAPLER (MANUAL), PHASE I EXPLORATORY STUDY. EVALUATE THE CUMULATIVE INCIDENCE OF ANASTOMOTIC LEAKAGE AFTER CREATION OF COLORECTAL ANASTOMOSIS WITH THE ETHICON CIRCULAR STAPLER (MANUAL) ¿ A REAL WORLD DATA ANALYSIS. BLEEDING AT LEAST ONE ICD9 DX CODE FOR BLEEDING POST A PROCEDURE WITH THE USE OF THE MEGADYNE ACE BLADE. SOURCE: DIAGNOSIS CODE ICD9. REOPERATION CPT CODE + READMISSION AFTER INITIAL ATTUNE KNEE JOINT REPLACEMENT SURGERY. SOURCE: PROCEDURE CODE. SURGICAL SITE INFECTION , ICD9 DX CODE. SOURCE: DIAGNOSIS CODE ICD 9 & ICD 10. SUBSEQUENT SURGERY AT 90-DAYS SUBSEQUENT SURGERIES WERE DEFINED AS THE FIRST PRIMARY OR SECONDARY PROCEDURE CODE OCCURRING WITHIN 90-DAYS OF THE INDEX SURGERY. SOURCE: PROCEDURE CODE. THIS IS FOR ETHICON. A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 19049981 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY A STAPLE LINE LEAK WITH ECS25B (CIRCULAR STAPLER -XL SEALED) THE SURGEON HAS BEEN USING ECS25B FOR ALMOST MORE THAN A YEAR. THE PATIENT SUFFERED A LEAK AND PNEUMONIA.

  Patient problems: Failure to Anastomose; Pneumonia

  MAUDE report 18758752 ↗
• InjuryFeb 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY A STAPLE LINE LEAK WITH ECS25B (CIRCULAR STAPLER -XL SEALED) THE SURGEON HAS BEEN USING ECS25B FOR ALMOST MORE THAN A YEAR. THE PATIENT SUFFERED A LEAK AND PNEUMONIA.

  Patient problems: Failure to Anastomose; Pneumonia

  MAUDE report 18758721 ↗
• MalfunctionFeb 21, 2024Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Failure to Fire; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ESOPHAGECTOMY THE STAPLE LINE LEAKS WITH ECS25B (CIRCULAR STAPLER -XL SEALED) THE SURGEON HAS BEEN USING ECS25B FOR ALMOST MORE THAN A YEAR, SO HE WAS SURPRISED TO SEE UNEXPECTED LEAKAGE. THERE WERE NO DONUTS, THE ANASTOMOSIS FAILED, AND HE HAD TO PERFORM SUTURE ANASTOMOSIS. PATIENT HAD PNEUMONIA, AND COULDN'T SURVIVE AS A RESULT OF THE PNEUMONIA.

  Patient problems: Failure to Anastomose; Pneumonia

  MAUDE report 18748859 ↗
• MalfunctionJan 31, 2024Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WAS A DIFFICULTY IN REMOVING THE ANVIL WHEN THE NURSE WAS PREPARING THE DEVICE FOR THE OPERATION. THERE WAS A DIFFICULTY IN ATTACHING THE ANVIL AND THE DEVICE WHEN ANASTOMOSIS. ANVIL IN THE QUESTION WAS USED AS IS, AND 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 18614087 ↗
• MalfunctionDec 19, 2023Failure to Form Staple; Patient Device Interaction Problem; Failure to Form Staple; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS AT THE GASTRO-JEJUNAL ANASTOMOSIS, AFTER THE STAPLING, THE SURGEON FELT A SLIGHT JUMP OF THE DEVICE WHEN IT WAS REMOVED. THE CUT OF THE TISSUE WAS PROPERLY PERFORMED. HOWEVER, ONE OF THE STAPLES WAS NOT COMPLETELY CLOSED. THIS LED TO A FISTULA WHICH WAS OBSERVED BY A BLUE TEST. THE FISTULA WAS CLOSED BY A MANUAL SUTURE, LEADING A SURGICAL DELAY.

  Patient problems: Fistula

  MAUDE report 18354567 ↗
• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OP OF A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE THAT THE PATIENT PRESENTED WITH BLEEDING THROUGH THEIR BOWELS WITH A BOWEL MOVEMENT. PATIENT WAS BROUGHT BACK TO THE ER THE EVENING OF (B)(6) 2023. DURING REOP BLEEDING WAS FOUND AROUND THE GASTROJEJUNOSTOMY AT THE STAPLE LINE. BLEEDING WAS CONTROLLED BY OVER SEWING THE EXTERIOR OF THE STAPLE LINE WHICH WAS SUCCESSFUL. PATIENT AS OF THE AM (B)(6) 2023 IS DOING FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18233607 ↗
• MalfunctionMar 13, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A GASTRIC BYPASS THE ANVIL WOULD NOT FIT ONTO THE TROCAR. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530174 ↗
• MalfunctionMar 7, 2023Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING THE GASTRIC BYPASS, WHEN USING THE DEVICE FOR GASTRO-JEJUNAL ANASTOMOSIS, THE DEVICE CUT THE TISSUES BUT DID NOT STAPLE. THE ANASTOMOSIS WAS NOT PERFORMED, AND THE TISSUES WERE TEAR. THE SURGEON WAS FORCED TO DO AGAIN THE GASTRIC PLASTY AND TAKE A NEW CIRCULAR DEVICE IN ORDER TO MAKE THE ANASTOMOSIS. THE OPERATIVE TIME HAS BEEN SIGNIFICANTLY EXTENDED. SO, THE ANESTHESIA WAS PARTICULARLY LONG FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16494961 ↗
• MalfunctionJan 10, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY THAT THE DOCTOR HAD A STAPLER MISFIRE. THE DEVICE CUT BUT THERE WEREN¿T ANY STAPLES AT ALL IN THE DEVICE. UNKNOWN OF ANY PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132783 ↗
• MalfunctionDec 19, 2022Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY AND SALPINGO-OOPHORECTOMY, GREATER OMENTUM RESECTION AND SIGMOIDECTOMY, THE ANVIL HEAD COULD NOT BE DISASSEMBLED FROM THE DEVICE BEFORE USE. 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 16006647 ↗
• MalfunctionDec 19, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING A ROUX-EN-Y WHILE OPENING THE DEVICE IT WAS DISCOVERED THAT THE ACCESSORY TROCAR WAS DAMAGED. A NEW DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT CONSEQUENCES. THERE WAS A 4-MINUTE DELAY IN THE SURGERY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005161 ↗
• MalfunctionOct 17, 2022Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN OPEN TOTAL GASTRECTOMY, THE ANVIL COULD NOT BE ATTACHED WITH THE TROCAR. 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 15615192 ↗
• MalfunctionAug 2, 2022Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ANVIL COULD NOT BE REMOVED FROM THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15146001 ↗