N/A ECS33ARecalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 10705036012412), received between Dec 1, 2017 and Sep 8, 2026 — classified as 1 death, 14 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (18 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 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026No Apparent Adverse Event

  It was reported that during an Unknown surgery, after fired, the staple line and cut line are both complete. noted oozing. To stop oozing with compression hemostasis. There were no adverse consequences to the patient. No additional information could be provided.

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

  MAUDE report 50669923 ↗
• MalfunctionNov 12, 2025Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE 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 23533148 ↗
• MalfunctionMar 13, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A COLECTOMY SURGERY, NOTED THE ANVIL LOCK-OUT LOOSE. 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 21596903 ↗
• MalfunctionMar 13, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A PROCTECTOMY SURGERY, NOTED THE ANVIL LOCK-OUT LOOSE. 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 21596656 ↗
• MalfunctionMar 5, 2025Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A GASTRIC PROCEDURE SURGERY, COULD NOT FIRE. 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 21525150 ↗
• MalfunctionJul 18, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A ESOPHAGEAL PROCEDURE THEY COULD NOT ATTACH THE ANVIL. OPENED THE PACKING AND FOUND COULD NOT ATTACH THE ANVIL. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344504 ↗
• MalfunctionJun 5, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A RECTUM PROCEDURE SURGERY, THE DEVICE COULD NOT FIRE. CHANGED TO 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 17057816 ↗
• MalfunctionMay 24, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE HEAD OF THE DEVICE CAME OFF. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994392 ↗
• InjuryMay 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A POST-OP LEAKAGE. 1-DAY AFTER SURGERY A LEAKAGE WAS NOTED. THE SURGERY PROCEDURE WAS NORMAL. PROCEDURE: UNKNOWN.

  Patient problems: Failure to Anastomose

  MAUDE report 16919020 ↗
• MalfunctionMar 30, 2023Failure to Form Staple; Failure to Fire; No Apparent Adverse Event; Failure to Form Staple; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED WHO WAS IN THE CASE THAT DURING A ROBOTIC LOW ANTERIOR RESECTION PROCEDURE THAT ON THE INITIAL ATTEMPT BY THE SURGICAL TECH DID NOT FULLY DEPRESS THE HANDLE AND THE STAPLES DID NOT FULLY DEPLOY. THE TECH THEN STARTED THE PROCESS TO REMOVE THE DEVICE WHEN IT WAS NOTICED THAT THE DEVICE DID NOT FULLY FIRE. SURGEON THEN ATTEMPTED TO COMPLETE THE FIRING SEQUENCE BUT DID NOT WAIT THE FULL FIFTEEN SECONDS BEFORE FIRING THE DEVICE. DEVICE WAS REMOVED, A LEAK TEST WAS PREFORMED, AND A LEAK WAS FOUND. SURGEON RESECTED MORE TISSUE AND USED A COMPETITOR¿S DEVICE TO COMPLETE THE ANASTOMOSIS. WHILE SURGEON WAS COMPLETING THE NEW ANASTOMOSIS THE REP EXAMINED THE INITIAL DEVICE AND FOUND SOME MALFORMED STAPLES LEFT BEHIND IN THE DEVICE. LEAK TEST WAS PERFORMED ON THE NEW ANASTOMOSIS AND NO LEAKS WERE FOUND. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16643989 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THERE WAS A PATIENT WITH A HISTORY OF DIVERTICULOSIS WHO UNDERWENT LAPAROSCOPIC SIGMOIDECTOMY ON (B)(6) 2020. ACCORDING TO MEDICAL RECORDS PROVIDED, A 33 MM EEA DILATOR WAS PLACED IN THE PATIENT¿S RECTUM AND A 33 MM STAPLER ADVANCED INTO THE RECTAL STUMP AND FIRED. THE SURGEON NOTED TWO INTACT TISSUE DONUTS, AND A LEAK TEST WAS NEGATIVE FOR LEAKS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON POSTOP DAY 2. SHE RETURNED ON POSTOP DAY 3 WITH PAIN AND FEVER AND SUBSEQUENTLY DEVELOPED AN ANASTOMOTIC LEAK, WHICH REQUIRED EXPLORATORY LAPAROTOMY, RESECTION OF THE ANASTOMOSIS WITH END COLOSTOMY. SHE ALSO DEVELOPED OTHER POST OPERATIVE COMPLICATIONS WITH EXTENDED RECOVERY AND THE COLOSTOMY WAS REVERSED THE FOLLOWING YEAR.

  Patient problems: Failure to Anastomose; Fever; Insufficient Information; Pain; Peritonitis; Sepsis

  MAUDE report 16022927 ↗
• InjuryNov 29, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA THE RISK MANAGER RECEIVED NOTICE OF LITIGATION FROM ATTORNEY FOR PATIENT WITH HISTORY OF DIVERTICULITIS WHO UNDERWENT SIGMOID RESECTION FOR ¿THE REMOVAL OF A LARGE MASS IN HIS COLON.¿ PLEADING FURTHER ALLEGES THAT ON POST OPERATIVE DAY FIVE, PATIENT WAS DIAGNOSED WITH SEPSIS AND RUSHED TO THE OPERATING ROOM FOR EMERGENCY SURGERY TO REPAIR A COLORECTAL ANASTOMOTIC LEAK. IT IS ALLEGED THAT THAT THE ANASTOMOTIC LEAK WAS CAUSED BY AN AREA OF NON-FUNCTIONAL STAPLES. PLEADING FURTHER STATES PATIENT HAD TO UNDERGO NUMEROUS OTHER SURGERIES, INCLUDING ¿THE PLACEMENT OF A VERY LARGE AREA OF MESH THROUGHOUT HIS ENTIRE ABDOMEN.¿

  Patient problems: Failure to Anastomose; Sepsis

  MAUDE report 15880209 ↗
• MalfunctionOct 3, 2022Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A LAPAROTOMY CONVERSION OF BILLROTH TO GASTRIC BYPASS PROCEDURE THAT WHILE CREATING THE ANASTOMOSIS ON THE GASTRIC POUCH THAT ONLY HALF OF THE OUTER ROW OF STAPLES DEPLOYED. THE STAPLES THAT WERE DEPLOYED WERE FULLY FORMED. A LITTLE OF THE TISSUE WAS TORN WHILE REMOVING THE DEVICE. ANASTOMOSIS WAS THEN OVER SEWN WITH SUTURE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15528192 ↗
• MalfunctionSep 15, 2022Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, COULD NOT FIRE. 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 15429477 ↗
• MalfunctionSep 9, 2022Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING THE RECTUM PROCEDURE, OPEN THE PACKING AND NOTED THAT SOME STAPLES FELL OFF. 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 15391332 ↗
• DeathMar 8, 2022Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE OPERATION WAS (B)(6) 2022 IN THE MEDICAL CENTER OF (B)(6). THE PATIENT DIED. THE AUTOPSY FOUND OUT THAT THE CIRCULAR SEAM WAS 0.8 CM LONG. THE DATE OF DEATH IS CLARIFIED. PROCEDURE: LAPAROTOMY

  Patient problems: Fluid Discharge; Insufficient Information; Multiple Organ Dysfunction Syndrome

  MAUDE report 13695574 ↗
• InjuryFeb 1, 2022Failure to Form Staple; Adverse Event Without Identified Device or Use Problem; Failure to Form Staple; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SIGMOID COLECTOMY PROCEDURE THAT AFTER COMPLETING THE FIRING SEQUENCE THE STAPLER SEEMED TO FIRE AS NORMAL AND THERE WERE TWO INTACT DONUTS. WHEN THEY WENT TO LOOK IN THE ABDOMEN THERE WAS ¿STOOL EVERYWHERE¿, THE STAPLES NEVER GRABBED THE TISSUE TO DO THE ANASTOMOSIS. SURGEON ENDED UP PREFORMED A COLOSTOMY ON THE PATIENT.

  Patient problems: Failure to Anastomose

  MAUDE report 13417377 ↗
• InjuryJan 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST OP OF A LOW ANTERIOR RESECTION, PATIENT WITH POST-OP BLEED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13308850 ↗
• MalfunctionJan 4, 2022No Apparent Adverse Event; Failure to Eject; No Apparent Adverse Event; Failure to Eject

  IT WAS REPORTED THAT DURING A COLECTOMY THE CIRCULAR STAPLER MISFIRED. CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154276 ↗
• MalfunctionAug 9, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING THE SURGERY, BEFORE USED ON THE PATIENT, NOTED THE PACKING WAS DAMAGED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293403 ↗
• MalfunctionJun 14, 2021Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING A SIGMOID RESECTION PROCEDURE THAT THE DEVICE MISFIRED AND ONLY DEPLOYED A HALF CIRCLE. ANASTOMOSIS WAS COMPLETED USING SILK SUTURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11991277 ↗
• MalfunctionMar 1, 2021Ejection Problem; Ejection Problem

  IT WAS REPORTED THAT DURING A HEMICOLECTOMY, THE ANCILLARY TROCAR COULD BE FITTED ONTO THE TROCAR OF ECS. BUT REMOVAL WAS VERY DIFFICULT. REMOVED IT BY LOT OF STRUGGLE. LATER THEY USED LINEAR CUTTER TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS COMPLETED AS USUAL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11394048 ↗
• MalfunctionOct 15, 2020Failure to Form Staple; Failure to Form Staple

  IT WAS REPORTED THAT DURING THE ENDOSCOPIC BOWEL SURGERY, AFTER FIRED, NOTED STAPLES MALFORMED WITH IRREGULAR SHAPE (WITH STRAIGHT LEG). 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; No Consequences Or Impact To Patient

  MAUDE report 10683154 ↗
• MalfunctionAug 10, 2020Failure to Form Staple; Failure to Form Staple

  SEE ATTACHED USER FACILITY MEDWATCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384755 ↗
• MalfunctionJul 24, 2020Firing Problem; Firing Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WOULDN'T FIRE. NO OTHER INFORMATION IS AVAILABLE. THERE WERE NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10323301 ↗