Surgical Stapler Complications
Surgical stapler and staple malfunctions during surgery can cause complications including bleeding, sepsis, organ and tissue damage, increased risk of cancer recurrence, and death. Common malfunctions include misshapen staples, stapler misfiring and use of improper staple size, all of which can prolong surgery and expose patients to serious complications. The FDA received more than 11,500 reports of serious surgical stapler complications from 2011 through 2018.
Surgical stapler and staple complications are often the result of malfunctioning devices. The devices are often used in place of sutures because they are generally faster and less painful for patients. The staplers are designed to implant several staples at once, quickly closing an incision or reconnecting tube-like structures, such as arteries or intestines. If they malfunction, they can damage nearby tissue or fail to fully close open incisions.
Complications from Surgical Stapler Malfunctions
Surgical stapler and staple malfunctions have resulted in thousands of serious complications. Malfunctions can prolong surgical procedures, keeping a patient under anesthesia longer than planned, which can present additional complications.
Staple injuries may cause bodily damage that can be corrected only through other surgical interventions.
- Bleeding, including internal bleeding
- Sepsis, a potentially fatal reaction to infection
- Fistula formation, abnormal connections between organs and tissues
- Tearing of internal tissues and organs
- Increased risk of cancer recurrence
Most Common Surgical Stapler Complications Resulting from Malfunctions
Surgical staples require accurate staple formation and placement to work as they should. Achieving a proper staple line is dependent on the proper function and use of the surgical stapler, according to the FDA.
Bleeding or the reopening of an incision can happen if the staple line isn’t complete or doesn’t hold.
- Difficulty in firing
- Failure of the stapler to fire the staple
- Malformation of staples
- Opening of the staple line
- User applying staples to the wrong tissue
- User applying the wrong size staples to tissue
Signs and Symptoms of Complications
Some complications may occur during surgery and may be immediately addressed by the surgical team. But some may not show up until days after surgery.
Surgical stapler complications can be serious, and you should seek immediate medical attention if you experience signs or symptoms.
- Yellow, brown or green discharge around the incision or staples
- Reopening of the incision
- Redness or swelling around or near the incision
- Red streaks moving outward from the incision
- New or severe pain
- Dryness or darkened skin around the staples
- Bleeding at the incision
- Fever of 100 degrees or higher, lasting four hours or longer
Injuries from Recalled Surgical Staplers
Manufacturers recalled more than 3.4 million surgical staplers, staples, cartridges and components between 2013 and 2019. Some of the recalls followed reports of defects that resulted in patient injuries. Others were issued after companies caught defects during manufacturing. Recalled devices have sometimes been named in surgical stapler lawsuits.
A 2019 recall of certain Medtronic Tri-Staple reloads and cartridges warned that the devices could cause complications such as bleeding, leaks between organs that had been reconnected with the staples, peritonitis, and a collapsed lung that could lead to infection and sepsis.
In a 2018 recall of Covidien Endo GIA Articulating Reloads, Medtronic reported at least five injuries. If misassembled, the device might fire an incomplete staple line. This could lead to bleeding or leakage of contents from the intestine to the body cavity.
Underreported Complications Led to FDA Crackdown
The U.S. Food and Drug Administration received nearly 110,000 reports of stapler malfunctions, injuries and deaths within a 7 year period that ended in 2018. More than 56,000 were hidden from public view in the FDA’s Alternative Summary Reporting system until 2019.
- Deaths – 412
- Injuries – 11,181
- Malfunctions – 98,404
Source: U.S. Food and Drug Administration, May 30, 2019
After the scale of surgical stapler malfunctions and complications became public, the FDA committed to preventing stapler and staple complications. The agency took steps to raise the device’s risk classification and enforce more rigorous marketing standards. It also issued new recommendations to doctors and hospitals and called in experts to analyze the reports it received on stapler malfunctions and complications.
FDA Instructions to Health Care Providers
The FDA issued a letter to doctors, hospitals and other health care providers in March 2019 regarding the dangers of surgical staplers and its new recommendations for preventing complications.
The letter highlighted the most common malfunctions and complications reported to the agency’s public database. The FDA had not yet analyzed information from its private Alternative Reporting System at the time.
- Read and carefully follow manufacturer’s instructions.
- Have a range of staple sizes available during surgery and use the correct type and size for the surgery.
- Consider other options if tissue may not support staples.
- Be familiar with surrounding organs, tissues and surgical tools that may be damaged by or interfere with the staples.
- Avoid using staples on large blood vessels such as the aorta.
- Avoid clamping staplers onto delicate tissue that could be damaged.
- Be prepared to clamp or close off blood vessels in the event of a malfunction when using staples to repair the vessels.
FDA Draft Guidance for Surgical Stapler Safety
The FDA proposed new labeling instructions for surgical staplers in April 2019. The draft guidance was intended to help doctors better understand risks and proper use of specific stapler models.
The guidance recommended that manufacturers provide instructions for when staplers should not be used, such as on dead tissue. It also suggested warnings against dangerous or risky uses, such as on large blood vessels.
According to the documentation, manufacturers should provide clear instructions for use. This included checking for proper staple placement. It also included clearly identifying technical specifications and limitations of the stapler.
FDA Moves to Reclassify Stapler Risk Level
The FDA announced in March 2019 that it was taking steps to reclassify surgical staplers for internal use as moderate-risk devices. The staplers had been considered low risk since 1988.
If the staplers are classified as low-risk, or Class I devices, manufacturers are not required to notify the FDA of new models or upgrades to existing models before selling them. Reclassifying internal surgical staplers as Class II, or moderate-risk, devices would mean that the FDA would have to clear new models before they hit the market.
Please seek the advice of a medical professional before making health care decisions.