ECHELON; ENDOPATH ECR60DRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endoscopic Linear Cutter Reloads Gold 3.8 mm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Echelon endoscopic stapler reload has 341 adverse event reports on file, with no deaths and 15 injuries. Most reports describe staples that did not form properly after firing, and some describe the stapler failing to fire. No recalls name this device. Reports in the last 12 months fell to 21 from 50 in the prior 12 months.
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
- 341
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 341 adverse event reports that list this exact device (DI 10705036011842), received between Nov 22, 2017 and Sep 21, 2026 — classified as 15 injuries, 326 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (182 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 Staple182
- Failure to Fire73
- Material Integrity Problem15
- No Apparent Adverse Event13
- Separation Problem10
- Break9
- Manufacturing, Packaging or Shipping Problem9
- Ejection Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions228
- No Consequences Or Impact To Patient95
- Hemorrhage/Blood Loss/Bleeding11
- No Code Available8
- Insufficient Information4
- Tachycardia2
- Abdominal Pain1
- Blood Loss1
Recent adverse event reports
The 25 most recent of 341 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50845931 ↗MalfunctionSep 21, 2026Failure to Fire
It was reported that during an unknown procedure, it was observed that the device could not be fired. 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 50840879 ↗MalfunctionAug 19, 2026Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325630 ↗MalfunctionMay 5, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083011 ↗MalfunctionApr 28, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017723 ↗MalfunctionApr 21, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING A GASTRO-INTESTINAL SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24943315 ↗MalfunctionApr 20, 2026Unintended Ejection
IT WAS REPORTED THAT DURING A HEPATOBILIARY PROCEDURE, IT WAS OBSERVED THAT THE NAIL BIN WING FELL OFF WHEN INSTALLED. 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 24928051 ↗MalfunctionApr 16, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24895394 ↗MalfunctionMar 20, 2026Failure to Fire
IT WAS REPORTED THAT DURING A LUNG RESECTION PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE 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 24650414 ↗MalfunctionFeb 18, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES MALFORMED AFTER FIRING. CHANGED TO ANOTHER FOUR TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE 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 24378078 ↗MalfunctionFeb 18, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES MALFORMED AFTER FIRING. CHANGED TO ANOTHER FOUR TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE 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 24378074 ↗MalfunctionFeb 17, 2026Delivered as Unsterile Product
IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE PACKAGING 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 24369012 ↗MalfunctionFeb 11, 2026Separation Problem
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE AND AFTER OPEN THE PACKING, THE SURGEON NOTED THAT THE IRON PLATE AT THE TAIL OF THE CARTRIDGE DEFORMED. SO COULD NOT INSTALL THIS RELOAD. CHANGED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24315304 ↗MalfunctionJan 16, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24100983 ↗MalfunctionJan 8, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24010441 ↗MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO ANOTHER ONE TO CONTINUE THE PROCEDURE BUT THE SAME PROBLEM HAPPENED AGAIN. CHANGED TO A NEW ONE 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 23809224 ↗MalfunctionNov 11, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526241 ↗MalfunctionNov 11, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526172 ↗MalfunctionNov 11, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525959 ↗MalfunctionNov 11, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23525647 ↗MalfunctionNov 4, 2025Failure to Form Staple; No Apparent Adverse Event; Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE STAPLER'S ANASTOMOSIS WAS INCOMPLETE, AND THERE WAS STILL BLEEDING AT THE INCISION. THEN, INTERMITTENT SUTURING WITH SILK THREAD WAS IMMEDIATELY PERFORMED TO STOP THE BLEEDING. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 23465481 ↗MalfunctionOct 27, 2025Ejection Problem; Ejection Problem
IT WAS REPORTED THAT DURING A DISTAL GASTRECTOMY PROCEDURE, THE SURGEON NOTED THAT IT WAS VERY DIFFICULT TO INSTALL THE CARTRIDGE AFTER OPENING THE PACKAGE. CHANGED TO ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23396711 ↗MalfunctionOct 27, 2025Failure to Form Staple; Failure to Form Staple
IT WAS REPORTED THAT DURING A GASTRECTOMY PROCEDURE, IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23393467 ↗MalfunctionOct 20, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT FIRE FARTHER AFTER FIRED A LITTLE. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23337586 ↗MalfunctionOct 15, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE DEVICE COULD NOT BE FIRED. CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23277428 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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