N/A ECS29ARecalls & reported problems
Ethicon Endo-Surgery, LLC · Endoscopic Curved Intraluminal Stapler (ILS) 24 Titanium Adjustable Height Staples · Class 2
Quick summary
This Ethicon ILS endoscopic stapler has 514 adverse event reports, including 1 death and 133 injuries. Many reports describe staples that do not form properly, the stapler failing to fire, and tissue that was not cut. Some describe bleeding and joins that did not form. No recalls name this device. Reports rose to 52 in the last 12 months from 29 in the year before.
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
- 519
- Deaths reported
- 1
- Injuries reported
- 133
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 519 adverse event reports that list this exact device (DI 10705036003502), received between Nov 29, 2017 and Sep 29, 2026 — classified as 1 death, 133 injuries, 385 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (173 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 Staple173
- Failure to Fire126
- Adverse Event Without Identified Device or Use Problem72
- Failure to Cut33
- Firing Problem26
- Ejection Problem22
- No Apparent Adverse Event17
- Misfire15
Patient problems
- No Clinical Signs, Symptoms or Conditions211
- No Consequences Or Impact To Patient176
- No Code Available87
- Failure to Anastomose72
- Blood Loss19
- Hemorrhage/Blood Loss/Bleeding12
- Insufficient Information5
- Abscess4
Recent adverse event reports
The 25 most recent of 519 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure 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 50931703 ↗MalfunctionSep 25, 2026Failure to Fire
It was reported that during an Unknown surgery, could not fire farther after fired a little. 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 50896489 ↗MalfunctionSep 22, 2026Failure to Form Staple
It was reported that during an Unknown procedure 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 50853400 ↗MalfunctionSep 21, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846229 ↗MalfunctionSep 15, 2026Failure 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 50772528 ↗MalfunctionSep 15, 2026Failure 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 50772439 ↗MalfunctionAug 13, 2026Delivered as Unsterile Product
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234199 ↗MalfunctionAug 5, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142671 ↗MalfunctionAug 3, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50122459 ↗MalfunctionJul 30, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081652 ↗MalfunctionJun 11, 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 25477921 ↗MalfunctionJun 8, 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 25436351 ↗MalfunctionMay 23, 2026Failure to Cut
IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THAT THE TISSUE WAS NOT CUT, CHANGED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264627 ↗MalfunctionMay 14, 2026Failure to Fire
IT WAS REPORTED THAT DURING A STOMA CLOSURE, RESTORATION OF RECTAL CONTINUITY. ACCORDING TO THE SURGEON, THE FIRST STAPLER FIRED THROUGH HALF OF THE ANASTOMOSIS, WITH THE STAPLE RINGS BEING INTACT AND UNDAMAGED, AND NO OPEN STAPLES REMAINING IN THE PATIENT. IT WAS DECIDED TO USE A SECOND STAPLER; THE STAPLED AREA WAS EXCISED, AND IN ACCORDANCE WITH THE INSTRUCTIONS, THE DEVICE WAS INTRODUCED, THE ANVIL WAS POSITIONED, MANDATORY PRE-COMPRESSION WAS PERFORMED, FOLLOWED BY FIRING. THE SECOND STAPLER FIRED THROUGH THREE-QUARTERS OF THE ANASTOMOSIS. THE REMAINING DEFECT OF THE ANASTOMOSIS WAS CLOSED WITH HAND-SEWN SUTURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25177187 ↗MalfunctionMay 14, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING THE PROCTRECTOMY 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 25174621 ↗MalfunctionMay 13, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING THE UNK 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 25165237 ↗MalfunctionMay 7, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RECTAL 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 25117815 ↗MalfunctionMay 4, 2026Structural Problem; Ejection Problem
IT WAS REPORTED THAT DURING THE LAP GASTRECTOMY SURGERY, AFTER FIRED, THE KNIFE MOVED TO THE DISTAL END, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. OPENED THE DEVICE MANUALLY WITH BIG FORCE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25074172 ↗MalfunctionMay 4, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE PROCTRECTOMY 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 25072396 ↗MalfunctionApr 24, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING THE LOW ANTERIOR RESECTION SURGERY. AFTER FIRED, NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. SUTURE WAS USED TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE REPORTED, NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 24983920 ↗MalfunctionApr 8, 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 24821934 ↗MalfunctionApr 3, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE RECTUM 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 24782371 ↗MalfunctionApr 2, 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 24769820 ↗MalfunctionApr 2, 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 24769795 ↗MalfunctionApr 2, 2026Structural Problem
IT WAS REPORTED THAT BEFORE THE UNK SURGERY, THE KNIFE MOVED TO THE DISTAL END, BUT COULD NOT RETURN KNIFE AUTOMATICALLY. KNIFE REVERSE BUTTON COULD NOT WORK. CHANGED ANOTHER ONE TO CONTINUE 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 24769104 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.