FDA Shocked by Spike in Malfunctioning Staplers

It's no secret that a stapler failure can quickly turn a routine procedure into an emergency. What's surprising is the alarming number of times staplers have misfired or failed to fire — and the number of patients that have been harmed or killed as a result. Over the last 7 years, malfunctioning surgical staplers have seriously injured more than 9,000 patients and killed 366 others, according to an analysis by the U.S. Food and Drug Administration, which last month sent healthcare professionals a letter warning them of the dangers (osmag.net/rAcBP5).

From Jan. 1, 2011, to March 31, 2018, the FDA says it received reports of more than 32,000 stapler and staple malfunctions. Among the most commonly reported problems: the opening of the staple line or malformation of staples; misfiring; difficulty in firing; failure of the stapler to fire staples; and misapplied staples (user applying staples to the wrong tissue or applying staples of the wrong size to the tissue.)

Stapler and staple malfunctions could result in prolonged surgical procedures or unplanned additional surgical interventions which may lead to complications, such as bleeding, sepsis, fistula formation, tearing of internal tissues and organs, increased risk of cancer recurrence and even death.

"If you look at the most commonly reported problems in the adverse event reports (in the FDA letter), opening of the staple line or malformation of staples, misfiring or difficulty in firing, most of those could be attributed to the wrong height of the staple," says David Renton, MD, MPH, FACS, chief of surgery at Ohio State University East Hospital.

Dr. Renton believes the FDA recommendations will urge healthcare providers to rethink what staplers they use. For example, if a motor-driven or electric stapler determines that the staple cartridge and the anvil are too far apart — meaning the tissue is too thick for that height of staple — it will not fire. It will stop you from doing it and give you feedback like, "tissue too thick, choose another cartridge."

"That may be a benefit of this — it will lead to an earlier adoption of staplers that offer feedback," says Dr. Renton. "Stapling has been around for a long time. It's not like we're suddenly doing it wrong. A lot of this is that we've used the same stapler since training, so that's what we're going to use. Surgeons are nothing if not creatures of habit. It can be difficult for us to accept new things."

The FDA's letter also states that the agency will consider reclassifying surgical staplers for internal use as Class II medical devices — which would subject them to premarket notification and let the FDA establish mandatory special controls to help mitigate known risks of the device.

The FDA offered the following recommendations:

• Read and carefully follow the stapler manufacturer's instructions for use.
• Have a range of staple sizes available and select the appropriate size cartridge for the tissue type and thickness.
• If you have difficulty squeezing the handle of the stapler, you may need to select a different size staple.
• Avoid using the stapler on tissue that is too thick or too thin for the selected staple size, as this could result in staple malformation.
• Be aware that different companies may use different color schemes to indicate different staple sizes.
• Consider other options if the patient's tissue is edematous (swollen with fluid), friable (tissue that readily tears, fragments or bleeds with gently palpated or manipulated), or necrotic (death of tissue) as the staples may be less likely to securely approximate tissue.
• Be familiar with the structures around the intended staple site and check that unintended structures — such as urinary bladder or foreign objects such as clips — are not in the staple line.
• Avoid using on large blood vessels, such as the aorta.
• Avoid clamping the stapler on delicate tissue, as clamping can cause injury even if no staple is fired.
• If a malfunction of the stapler occurs while applying staples across a blood vessel, then clamp or ligate the vessel before releasing the stapler while it is still closed on the tissue.

But these recommendations won't do much additional good unless there is a better system in place for reporting device failures, according to one doctor.

"We need a real-time, transparent system to move information to the people who need it. And the people who actually need it the most are the companies, with the FDA providing oversight," says Steven Schwaitzberg, MD, FACS, professor and chairman of the University at Buffalo Department of Surgery. "The companies need to know today if a stapler failed. So, if one fails tomorrow, they can start putting the pieces together."

The FDA says it will issue a draft guidance for public comment later this year, which will describe the proposed recommendations to manufacturers of surgical staplers and staples for internal use about information to include on their product labeling. Dr. Schwaitzberg sees the need for a better system of reporting device failures.

"It's not that staplers are falling apart left and right every day. We just have to have a will and a commitment to a culture of safety," he says. "And the healthcare community needs to commit to having a workable, straightforward, transparent reporting process so that we can clearly understand whether there are devices that need to be improved." OSM