N/A ECS25ARecalls & reported problems
Ethicon Endo-Surgery, LLC · Endoscopic Curved Intraluminal Stapler (ILS) 20 Titanium Adjustable Height Staples · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon curved intraluminal stapler is an endoscopic stapler used to join tissue. The 235 reports mostly describe staples that did not form or fire properly, and some describe staples formed incorrectly, with surgeons finishing with a new stapler or sutures. The reports include 32 injuries and no deaths, and reports rose to 36 in the last 12 months from 17 in the 12 months before. 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
- 233
- Deaths reported
- 0
- Injuries reported
- 32
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 10705036003496), received between Dec 1, 2017 and Sep 25, 2026 — classified as 32 injuries, 201 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (82 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.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple82
- Failure to Fire72
- Ejection Problem23
- Adverse Event Without Identified Device or Use Problem15
- No Apparent Adverse Event13
- Failure to Cut11
- Appropriate Device Problem Term/Code Not Available8
- Firing Problem7
Patient problems
- No Clinical Signs, Symptoms or Conditions157
- No Consequences Or Impact To Patient45
- No Code Available20
- Failure to Anastomose16
- Hemorrhage/Blood Loss/Bleeding9
- Blood Loss3
- Post Operative Wound Infection2
- Tissue Damage2
Recent adverse event reports
The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896462 ↗MalfunctionSep 25, 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 50896249 ↗MalfunctionSep 16, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788054 ↗MalfunctionAug 13, 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. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235996 ↗MalfunctionJun 29, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING THE PROCTRECTOMY 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 25652969 ↗MalfunctionJun 18, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE RECTUM 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 25553372 ↗MalfunctionMay 26, 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 25281089 ↗MalfunctionMay 23, 2026Ejection Problem
IT WAS REPORTED THAT BEFORE THE PROCTOCOLECTOMY SURGERY, NOTE THE SPRING PLATE OF THE ANVIL WAS 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 25264698 ↗MalfunctionMay 7, 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 25113519 ↗MalfunctionApr 22, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING THE UNK SURGERY. AFTER FIRED, NOTED THAT A FEW STAPLES FORMED WITH IRREGULAR SHAPES AND ANASTOMOTIC SITE WAS OOZING. TO STOP OOZING WITH COMPRESSION HEMOSTASIS. 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 24956678 ↗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 24956591 ↗MalfunctionApr 9, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE ESOPHAGECTOMY 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 24831343 ↗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 24769862 ↗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 24747829 ↗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 24747793 ↗MalfunctionMar 30, 2026Failure to Fire
IT WAS REPORTED THAT DURING LAP NEPHRECTOMY 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 24731419 ↗MalfunctionMar 30, 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 24718605 ↗MalfunctionFeb 24, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN 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 24433701 ↗MalfunctionFeb 20, 2026Ejection Problem
IT WAS REPORTED THAT BEFORE THE UNK SURGERY, OPEN THE PACKING AND NOTED COULD NOT DETACH THE ANVIL. CHANGED THE NEW ONE TO COMPLETE SURGERY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24405540 ↗MalfunctionFeb 20, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING THE LAP GASTRECTOMY 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 24401700 ↗MalfunctionFeb 18, 2026Failure to Cut
IT WAS REPORTED THAT DURING THE UNK SURGERY, AFTER FIRED, NOTED THAT THE TISSUE WAS NOT CUT COMPLETELY. THEN CHANGED THE NEW ONE 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 24381921 ↗MalfunctionFeb 18, 2026Failure to Fire
IT WAS REPORTED THAT DURING THE LAP GASTRECTOMY 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 24381647 ↗MalfunctionFeb 9, 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 24294660 ↗MalfunctionJan 8, 2026Failure 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 24005720 ↗MalfunctionJan 5, 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 23966974 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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