Ethicon Surgical Stapler Recall Issued After Patient Died When Device Failed Mid-Surgery

Doctors indicate they are being “locked out” of surgical staplers in the middle of procedures, which can lead to life-threatening hemorrhages for patients.

Federal regulators warn that nearly 700,000 Ethicon surgical stapler reloads may cause the devices to suddenly stop working in the middle of surgery, which has already led to at least one reported death and one injury.

The U.S. Food and Drug Administration (FDA) announced the Endopath Echelon surgical stapler reload recall on July 25, classifying it as a Class I recall due to the risk of serious injury or death to patients.

The affected devices are stapler reloads for the Echelon Flex Powered Vascular Stapler, which both cuts and staples tissue at the same time. Surgeons commonly rely on the staplers for precise tissue control, especially in procedures where bleeding must be quickly contained.

However, the recall notice warns that the device may inadvertently lock during surgery, preventing it from cutting or stapling tissue despite briefly activating, and resulting in the need for additional steps to open and remove the stapler from tissue.

Under these conditions, the knife stops cutting and staples remain below the tissue contact surface. The lockout feature is supposed to protect the patient by stopping the stapler from firing if they are loaded incorrectly.

Ethicon Endo-Surgery, LLC, the manufacturer, originally notified its customers of the problem in a device correction notice issued in April, warning about reports of doctors being locked out of using the device mid-surgery. 

The recall affects the Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row), with product code VASECR35 and a Unique Device Identifier (UDI) of 10705036014591, involving 57 affected lots and an estimated 678,526 devices.

It is unclear from the recall notice whether the reported problems were caused by the reloads being loaded improperly. However, the FDA warns that these impacted staplers can fail during use, potentially leading to severe bleeding, surgical delays or death.

Ethicon Endo-Surgery, LLC indicates that representatives from the company will contact customers to ensure they are updated on the proper instructions for use.

Customers with questions can contact the Ethicon Resource Department at 1-877-384-4266.

Other Surgical Stapler Problems

This recall is the latest issue to plague surgical staplers in recent years. In March 2019, the FDA announced it had received at least 41,000 adverse event reports linked to surgical stapler failures between January 2011 and March 2018, including 366 patient deaths. That year, the agency introduced new standards to make the devices safer for patients.

The most commonly reported problems linked to surgical staplers involve an opening of the staple line, malformation of staples, staplers misfiring, staplers being too difficult to fire, staplers failing to fire and staplers that were misapplied. The FDA indicates stapler malfunctions or misuse can cause prolonged surgical procedures, the need for additional surgeries, and other complications, such as bleeding, sepsis, internal organ damage and death.

A number of surgical stapler lawsuits have been pursued against Covidien and other manufacturers in recent years, each raising similar allegations that design defects caused the devices to misfire, fail to fire or issue malformed staples, which can cause devastating internal injuries and organ perforations.

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