Echelon Endopath GST60BRecalls & reported problems
Ethicon Endo-Surgery, LLC · Endopath Echelon Endoscopic Linear Cutter Reloads, Blue, 60mm · Class 2 · Implant
Quick summary
This Ethicon Endopath Echelon stapler reload appears in 867 adverse event reports, including 8 deaths and 68 injuries. Many describe staples not forming properly or the stapler failing to fire, with some mentioning packaging tears and pieces falling off after firing. Some reports mention bleeding and failed tissue connections in patients. 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
- 867
- Deaths reported
- 8
- Injuries reported
- 68
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 867 adverse event reports that list this exact device (DI 10705036014706), received between Nov 20, 2017 and Sep 28, 2026 — classified as 8 deaths, 68 injuries, 791 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (323 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 Staple323
- No Apparent Adverse Event204
- Failure to Fire132
- Device Markings/Labelling Problem93
- Tear, Rip or Hole in Device Packaging60
- Adverse Event Without Identified Device or Use Problem44
- Material Integrity Problem43
- Detachment of Device or Device Component19
Patient problems
- No Clinical Signs, Symptoms or Conditions654
- No Consequences Or Impact To Patient144
- Hemorrhage/Blood Loss/Bleeding59
- Failure to Anastomose26
- No Code Available12
- Abscess9
- Blood Loss8
- Foreign Body In Patient6
Recent adverse event reports
The 25 most recent of 867 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916647 ↗MalfunctionSep 21, 2026Failure to Form Staple
It was reported that during a Proctocolectomy procedure, it was observed that the staples were malformed after firing. Suture was used to oversew. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841253 ↗MalfunctionSep 21, 2026No Apparent Adverse Event
It was reported that during a Laparoscopic Lobectomy, the surgeon found that a large amount of the staples fell off and scattered in the thoracic cavity after the device firing was completed; and only a small amount of the staples remained in the marginal tissue of the anastomosis. Immediately and completely counted and removed all scattered staples, and repeatedly flushed the thoracic cavity with normal saline to confirm that there is no residual foreign body. Changed another one to continue the surgery but the same problem happened again. Changed another one to continue the surgery, It was reported that during the surgery, could not fire. Changed the new one to complete surgery. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840139 ↗MalfunctionSep 21, 2026Failure to Form Staple
It was reported that during an unknown procedure, it was observed that some staples were malformed with irregular shape after firing. Used suture to oversew. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839503 ↗MalfunctionAug 30, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514073 ↗MalfunctionAug 30, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514069 ↗MalfunctionAug 28, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50501446 ↗InjuryAug 21, 2026Material Integrity Problem
It was reported that during an unspecified surgical procedure, it was observed that a blue speck fell off after firing. Additional information requested.
Patient problems: Foreign Body In Patient
MAUDE report 50374676 ↗MalfunctionAug 20, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50348690 ↗MalfunctionAug 19, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331075 ↗MalfunctionAug 19, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50331038 ↗MalfunctionAug 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50255841 ↗MalfunctionAug 14, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254421 ↗MalfunctionAug 10, 2026Structural Problem
t was reported that during an unknown procedure, it was observed that some staples fell off when they opened the packaging. 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 50195238 ↗MalfunctionJun 19, 2026Structural Problem; Difficult to Open or Close; Mechanical Jam
IT WAS REPORTED THAT DURING A LYMPHADENECTOMY WITH RECTOSIGMOIDECTOMY, WHILE STAPLING THE SIGMOID, A GST60B EXHIBITED PREMATURE FIRING. THE SURGEON WAS INSTRUCTED TO REVERSE THE BLADE; AFTER APPROXIMATELY THREE REVERSALS THE STAPLER COULD BE OPENED. ON THE NEXT CARTRIDGE THE FIRST FIRE OCCURRED (FLEX STAPLER) AND THE INSTRUMENT JAMMED AGAIN WITH THE GST60B CARTRIDGE. WE REPEATED THE ENTIRE REVERSAL PROCESS AND THE STAPLER OPENED. THE CARTRIDGE WAS REPLACED WITH ONE FROM A DIFFERENT LOT AND THE SURGERY PROCEEDED. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25565917 ↗MalfunctionJun 16, 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 25523804 ↗MalfunctionJun 9, 2026Failure to Fire
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL 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 25444613 ↗MalfunctionJun 8, 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 25428697 ↗MalfunctionMay 29, 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 25334738 ↗MalfunctionMay 19, 2026Failure to Form Staple
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE; IT WAS OBSERVED THAT THE STAPLES WERE MALFORMED AFTER FIRING. THEY USED SUTURE TO OVERSEW. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216843 ↗MalfunctionMay 5, 2026Failure to Form Staple; No Apparent Adverse Event
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT A FEW STAPLES WERE FORMED WITH IRREGULAR SHAPES AFTER FIRING; AND ANASTOMOTIC SITE WAS OOZING. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. THEY USED AN ELECTRIC KNIFE TO TREAT COAGULATION. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 25083975 ↗MalfunctionMay 4, 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 25071417 ↗MalfunctionMay 4, 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 25071313 ↗MalfunctionApr 30, 2026Failure to Fire
IT WAS REPORTED THAT DURING A LOBECTOMY PROCEDURE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT FIRE FARTHER AFTER FIRED A LITTLE. CHANGED THE NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045158 ↗MalfunctionApr 30, 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 25043553 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.