FDA Experts to Meet Today on Internal Surgical Staplers

Published on May 30, 2019 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) will convene a panel of expert advisers today to address safety issues surrounding the use of internal surgical staplers and implantable staples.

According to a posting on the agency’s website, the advisers will be asked:

• If the FDA’s understanding of the issue is accurate and thorough.
• Whether there’s reasonable assurance that surgical staplers are safe and effective.
• Whether the agency’s proposed special controls are appropriate.
• Their opinion on the FDA’s proposal to reclassify internal surgical staplers as Class II medical devices, which would subject the products to greater regulatory scrutiny.

Surgical Stapler Injuries and Deaths

Internal surgical staplers may be manual or powered. They are used to cut tissue, remove organs, and create connections between structures during a variety of thoracic, gynecological, and gastrointestinal procedures.

Earlier this year, however, the FDA acknowledged that internal surgical stapler systems had been implicated in more than 41,000 adverse event reports since January 1, 2011. These reports detailed 366 patient deaths, 9,000 serious injuries, and 32,000 stapler malfunctions.

Some of the most commonly reported problems included:

• Opening of the staple line or malformation of staples.
• Misfiring, difficulty in firing or failure of the stapler to fire the staple.
• The application of staples to the wrong tissue or using the wrong size staples.

Internal surgical staplers are currently classified as Class I (low risk) medical devices.

“Reclassification of surgical staplers for internal use as a Class II device would allow the agency to require premarket review and allow us to establish special controls, such as mandatory performance testing of various mechanical features, demonstration of usability and labeling comprehension such as assessing health care professionals’ ability to properly select and use the device according to the labeling, and specific labeling elements supporting the safe use of the device,” Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health said in a statement published in March.

Ethicon Surgical Stapler Recall

Earlier this month, the FDA declared a surgical stapler recall recently announce by Ethicon a Class I recall, its most serious designation. This indicates that the affected products pose a significant risk of patient injury or death.

The Ethicon surgical stapler recall involved two products:

• Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples
• Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples

According to the FDA, at least two patients were injured when these staplers misfired.