ECHELON FLEX PSEE60ARecalls & reported problems
Ethicon Endo-Surgery, LLC · ECHELON FLEX Powered Plus Articulating Endoscopic Linear Cutter , 60mm · Class 2
Quick summary
This Ethicon Echelon Flex endoscopic stapler is a surgical device that cuts and staples tissue. Its 3,278 reports mostly describe the stapler failing to fire, being hard to open or close, and failing to form staples. The reports include 13 deaths and 282 injuries. There is 1 closed recall, begun in June 2021, for packages labeled 60mm that contained devices of a different size.
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
- 3,294
- Deaths reported
- 13
- Injuries reported
- 283
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3,294 adverse event reports that list this exact device (DI 10705036014607), received between Oct 25, 2017 and Sep 28, 2026 — classified as 13 deaths, 283 injuries, 2,998 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (1,060 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Jun 3, 2021Terminated
Mislabeled: Labeled on the package as 60mm contains 45mm devices
Z-2326-2021 · Root cause: Packaging change control · FDA record ↗
Most reported problems
Device problems
- Failure to Fire1,060
- Difficult to Open or Close997
- Failure to Form Staple582
- Mechanical Jam403
- Activation Failure246
- Adverse Event Without Identified Device or Use Problem193
- Material Integrity Problem136
- No Apparent Adverse Event128
Patient problems
- No Clinical Signs, Symptoms or Conditions2,248
- No Consequences Or Impact To Patient747
- Hemorrhage/Blood Loss/Bleeding181
- Failure to Anastomose77
- No Code Available74
- Blood Loss40
- Insufficient Information32
- Unspecified Tissue Injury22
Recent adverse event reports
The 25 most recent of 3,294 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923188 ↗MalfunctionSep 28, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50920335 ↗MalfunctionSep 28, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919308 ↗MalfunctionSep 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 50916746 ↗MalfunctionSep 25, 2026Difficult to Open or Close
It was reported that during an unknown procedure, it was observed that they could not close the jaw after clamping the tissue. 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 50898830 ↗InjurySep 25, 2026Patient Device Interaction Problem
Patient problems: Insufficient Information
MAUDE report 50898806 ↗MalfunctionSep 24, 2026Failure to Cut
It was reported that during an unspecified surgical procedure of the Pancreas, it was observed that the device did not fire farther after it fired a little. 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 50883719 ↗MalfunctionSep 24, 2026Failure to Form Staple
It was reported that during a Laparoscopic Lobectomy 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 50883221 ↗MalfunctionSep 24, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883201 ↗MalfunctionSep 24, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883163 ↗MalfunctionSep 21, 2026Self-Activation or Keying
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846200 ↗MalfunctionSep 21, 2026Failure to Form Staple; No Apparent Adverse Event
It was reported that during an unknown 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, the same problem happened again. Used suture 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 50841412 ↗MalfunctionSep 21, 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 50839451 ↗MalfunctionSep 18, 2026Failure to Fire; Difficult to Open or Close; Activation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829387 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Failure to Anastomose
MAUDE report 50828441 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Failure to Anastomose
MAUDE report 50826349 ↗MalfunctionSep 18, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50824613 ↗MalfunctionSep 18, 2026Failure to Form Staple; Failure to Cut; Failure to Fire; Difficult to Open or Close; Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820586 ↗MalfunctionSep 18, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820429 ↗MalfunctionSep 17, 2026Failure to Form Staple; Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury
MAUDE report 50808531 ↗MalfunctionSep 17, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806252 ↗MalfunctionSep 4, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50608822 ↗MalfunctionSep 1, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541461 ↗MalfunctionAug 31, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519691 ↗MalfunctionAug 25, 2026Ejection Problem
It was reported that during an unknown procedure, it was observed that a piece of the stapler load broke and got left behind in the stapler. New stapler was opened. No patient harm was reported. No additional information provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50431399 ↗
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- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
- ECHELON FLEX PVE35AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE29 deaths1,880 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.