J&J’s Ethicon Provides Correction for Echelon Disposable Surgical Stapler Cartridge

The U.S. Food and Drug Administration (FDA) issued a correction for surgical staple cartridges from Johnson & Johnson MedTech’s Ethicon Endo-Surgery. This doesn’t involve removing them from where they’re used or sold.

Ethicon provided a correction because of an inadvertent lockout during surgical procedures. The company reported the device will momentarily activate but won’t cut or staple tissue when this occurs, and further steps will be required to open it and remove it from the tissue.

The company said the device was designed so an instrument lockout shouldn’t lead to patient harm. During a lockout, the device might briefly activate but won’t cut or staple tissue. The knife doesn’t advance far enough to cut, staples remain below the tissue contact surface, and a built-in gap between the anvil and staple cartridge face helps prevent vessel injury during clamping and unclamping.

The Echelon Flex Powered Vascular Stapler with Advanced Placement Tip and Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 Row) reloads are sterile, single patient use devices that simultaneously cut and staple tissue. There are four staggered rows of staples, two on either side of the cut line.

This reload is used exclusively with the Echelon Flex Powered Vascular Stapler, product code PVE35A. The instrument’s lockout feature is designed to prevent a used or improperly installed reload from being fired, or an instrument from being fired without a reload.

Ethicon advised all personnel using the Endopath Echelon Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row), product code VASECR35 understand the instructions for use for the Echelon Flex Powered Vascular Stapler (product code PVE35A).

Affected lots can be found on the FDA notice.