N/A ECS21ARecalls & reported problems
Ethicon Endo-Surgery, LLC · Endoscopic Curved Intraluminal Stapler (ILS) 16 Titanium Adjustable Height Staples · Class 2
Quick summary
This Ethicon curved stapler is used to close and cut tissue during internal surgery, including rectal and stomach operations. Reports mostly describe the stapler failing to fire or forming malformed staples, sometimes leaving tissue uncut or the surgical site bleeding and needing extra suturing; surgeons typically switched to another device to finish the case. There are 36 reports, including 2 deaths and 3 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 2
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10705036003489), received between Apr 27, 2018 and May 4, 2026 — classified as 2 deaths, 3 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (14 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.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple14
- Failure to Fire5
- Adverse Event Without Identified Device or Use Problem3
- Ejection Problem3
- Failure to Cut3
- Delivered as Unsterile Product2
- Difficult to Remove2
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient6
- Hemorrhage/Blood Loss/Bleeding3
- Death2
- Abdominal Pain1
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Unspecified Tissue Injury1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING THE RECTAL OPERATION SURGERY, AFTER FIRED, NOTED SOME STAPLES MALFORMED AND OOZING OCCURRED. SUTURE WAS USED TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 25072639 ↗MalfunctionApr 22, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING THE UNK 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 24956554 ↗MalfunctionMar 31, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE UNK 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 24747850 ↗MalfunctionFeb 20, 2026Failure to Form Staple; Failure to Cut; No Apparent Adverse Event
IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THAT THE TISSUE WAS NOT CUT, AND NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. CHANGED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 24405853 ↗MalfunctionJan 23, 2026Failure to Fire
IT WAS REPORTED THAT DURING UNK PROCEDURE, 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 24165151 ↗MalfunctionOct 15, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A RECTUM PROCEDURE SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23289799 ↗MalfunctionSep 18, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING A LAP GASTRECTOMY SURGERY, AFTER FIRED, NOTED THE CUT LINE WAS OK, BUT WITHOUT ANY STAPLES. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23083055 ↗MalfunctionSep 9, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT DURING AN ESOPHAGEAL SURGERY, BEFORE USED ON THE PATIENT, NOTED THE INNER 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 23003131 ↗MalfunctionAug 8, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN 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 22749676 ↗InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POST OP TO AN UNKNOWN SURGERY, A FEW DAYS, THE PATIENT EXPERIENCED BLEEDING. THERE IS NO ANY OTHER INFORMATION COULD BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 21722322 ↗MalfunctionSep 3, 2024Ejection Problem; Ejection Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ANVIL WHEN REMOVED IS EJECTED UNDER PRESSURE, CAUSING IT TO BECOME CONTAMINATED AND FOR THIS REASON, THE DEVICE HAD TO BE CHANGED FOR ANOTHER OF THE SAME REFERENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20127625 ↗InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Ejection Problem; Adverse Event Without Identified Device or Use Problem; Ejection Problem
IT WAS STATED THE PATIENT UNDERWENT A LAPAROTOMY, COLOSTOMY TAKEDOWN, AND DIVERTING LOOP ILEOSTOMY CREATION. IT WAS FURTHER REPORTED ¿DURING THE FIRING OF THE STAPLER, THE ANVIL SEPARATED FROM THE DEVICE-REMAINING INSIDE OF PATIENT. ANVIL WAS RETRIEVED, CAUSING DAMAGE¿. THE ILEOSTOMY WAS REVERSED SIX MONTHS LATER.
Patient problems: Unspecified Tissue Injury
MAUDE report 19551088 ↗MalfunctionMay 13, 2024Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A DISTAL GASTRECTOMY 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 19297705 ↗MalfunctionSep 14, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT DURING AN ESOPHAGEAL SURGERY, OPEN THE PACKAGE AND NOTED THAT SOME STAPLES PROTRUDING. 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 17749467 ↗MalfunctionMay 15, 2023Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE ESOPHAGUS SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16931486 ↗MalfunctionMar 13, 2023Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE RIGHT HEMICOLECTOMY 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 16528641 ↗MalfunctionMar 6, 2023Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE ESOPHAGUS 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 16484666 ↗MalfunctionNov 4, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE THE SURGERY, BEFORE USED ON THE PATIENT, THE PACKAGE WAS FOUND DAMAGED. CHANGED ANOTHER ONE TO COMPLETE SURGERY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED. PROCEDURE: RIGHT HEMICOLECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15727654 ↗MalfunctionJul 11, 2022Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE ESOPHAGEAL SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 14977948 ↗MalfunctionJul 11, 2022Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE ESOPHAGEAL SURGERY, AFTER FIRED, NOTED THE STAPLES MALFORMED. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 14977883 ↗MalfunctionJul 8, 2022Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE 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. PROCEDURE: DISTAL GASTRECTOMY
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14960601 ↗MalfunctionJun 21, 2022Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING THE 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. PROCEDURE: RIGHT HEMICOLECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14753287 ↗MalfunctionMay 10, 2022Failure to Cut; Failure to Cut
IT WAS REPORTED DURING THE SURGERY, AFTER FIRED AND REMOVED THE DEVICE, NOTED THAT THE SUTURE WAS NOT CUT . THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION CAN BE PROVIDED. PROCEDURE: LAP GASTRECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14345302 ↗MalfunctionApr 27, 2022Ejection Problem; Ejection Problem
IT WAS REPORTED THAT DURING A ROUX-EN-Y THE SECOND TIME THEY HAD THE ANVIL STUCK IN THE UPPER ESOPHAGUS. THEY WERE ABLE TO BRING IT BACK UP BUT REALLY HAD TO WORK AT IT FOR THIRTY PLUS MINUTES. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14219951 ↗MalfunctionJun 24, 2021Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING RADICAL RESECTION OF ESOPHAGEAL CARCINOMA SURGERY, AFTER FIRED, NOTED SOME 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 12061473 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.