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Recall Observatory FDA recall evidence

Device product

ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 340mm shaft, Product Code PSEE60A

Z-0203-2020

October 03, 2019

Class I

Product summary

Firm
Ethicon Endo-Surgery Inc
Event
Event 83897
Status
Terminated
Classification
Class I
Quantity
2112 units
Official record key
device-enforcement:Z-0203-2020

Official wording

Reason: The staplers may contain an out of specification anvil component within the jaw of the device. This condition may lead to malformed staples, which can compromise staple line integrity. If the staple line is compromised, there is a potential risk of prolonged surgery, postoperative anastomotic leak, hemorrhage, hemorrhagic shock, additional surgical intervention, or death.

Code information: Lot: T93Z5W, T93Z5X, T9405V, T9405W, T93Z3F, T9401L, T93Y8X, T94008, T9400D, T93Z5R

Distribution pattern: Worldwide distribution. US Nationwide. Belgium, Brazil, Canada, Chile, Colombia, Japan, Kuwait, Saudi Arabia, and Singapore.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification