Surgical staplers are often used in place of sutures in certain types of surgeries. Unfortunately, many surgical staplers are prone to malfunction resulting in serious injuries to the patient. Surgical stapler injuries include infections, internal bleeding, organ damage, and even death.
Hundreds of surgery patients who were injured by a malfunctioning surgical stapler have filed lawsuits against the manufacturer and recovered financial compensation. On this page, we will look at surgical stapler lawsuits and their potential settlement value.
Surgical Staplers
Surgical staplers have become a common tool in modern medicine, offering a faster and more efficient method for closing wounds and surgical incisions. Compared to traditional suturing, staplers reduce operating time and improve precision, especially during complex surgeries like bariatric or gastrointestinal procedures. Despite these advantages, surgical staplers are not without significant risks, and their use has been associated with numerous complications and failures. These issues, particularly with certain models, have led to growing concerns about the safety of these devices.
Surgical staplers are used in both open and minimally invasive surgeries to close incisions or resections by applying rows of staples to the tissue. They are often preferred over sutures because they offer stronger and more consistent closures, reducing the risk of leaks from the site of anastomosis (a surgical connection between two structures). For example, in gastrointestinal surgeries, staplers are used to cut and seal parts of the stomach or intestines quickly and efficiently, which is critical when working with delicate tissues.
There are two primary types of surgical staplers: linear and circular. Linear staplers are used to close long, straight incisions, while circular staplers are used for creating circular anastomoses, such as those in the digestive tract. These devices also come in different sizes and can be loaded with different staple cartridges to match the thickness and nature of the tissue being stapled.
These staplers are used in general surgery as well as thoracic surgery, bariatric surgery, and colo-rectal surgery. Most staplers are categorized as either linear or circular. Circular staplers are often used in surgeries of the digestive tract and colon. Linear staplers are used primarily to connect tissues after the removal of organs.
Typically, linear staplers fire two staggered rows of staples from a linear cartridge, which allows the stapler to connect two sections of tissue, after a portion has been cut. A built-in blade then cuts off the overlaying tissue, sealing the new connection.
The main benefit of surgical staplers is that they allow surgeons to staple together tissue inside the body during minimally invasive (laparoscopic) surgical procedures. This makes large incisions unnecessary because the surgical stapler can fit into a small external opening. For this reason, surgical staplers are most frequently used in laparoscopic surgeries.
Surgical Stapler Failures and Malfunctions
Surgical staplers have come under scrutiny in recent years due to reports of serious complications and injuries. These devices, used in both internal and external surgical procedures, were originally introduced as a faster alternative to traditional sutures. However, an increasing number of surgical stapler lawsuits have been filed, alleging that defective staplers have led to severe injuries, prolonged recovery times, and even death.
This is because despite their advantages, surgical staplers have a long history of failures, defects and malfunctions. When these events occur, they tend to cause major injuries to the patient. Some of the more common types of surgical stapler malfunctions resulting in injuries include
- Misfires: occur when the mechanism that compresses the staple does not function properly for some reason. This can cause the staples to become disfigured or not properly formed when implanted, resulting in an improper or weak tissue connection or worse. This has led to injuries leading to complications such as internal bleeding, tissue damage, and infections. In extreme cases, these injuries have required additional surgeries to correct the damage caused by the malfunction. Misfired staples can also cause fistula formation, where abnormal connections between organs develop, creating even more significant health risks.
- Jamming: when the surgical stapler jams during a procedure the device frequently becomes stuck in the patient’s tissue, resulting in major internal damage.
- Missing Staples: one of the most frequent malfunctions with surgical staplers occurs when the device does not fire or insert all of the staples, leaving blank spaces and an unseal incision. This leaves the incision or resection site open and vulnerable to infection or bleeding.
- Anastomotic leaks: when the staples do not form correctly or if there is a failure in the staple line, digestive fluids or other bodily substances will leak into surrounding areas, causing infections, sepsis, or organ damage.
In many cases, the manufacturers promote surgical staplers for use in dangerous situations. In some types of surgery, it can be difficult or impossible to determine how thick the tissue being stapled is. Not knowing means that the surgeon can choose the wrong staple—too small and the area won’t be totally closed, causing leakage or bleeding; too large and the staple can cause more internal damage.
When damage is done, particularly during internal surgery, the patient may appear to be fine for a few days. However, internal bleeding and leakage can cause symptoms such as pain, vomiting, and infection. Doctors must be prepared to address those problems in order to determine the cause.
FDA Adverse Event Reports on Surgical Staplers
The evidence of just how often surgical staplers malfunction can be found in the sheer volume of adverse event reports reported to the FDA through the Manufacturer and User Facility Device Experience (MAUDE) database.
As the use of surgical staplers expanded, adverse event reports surged. By 2024, the FDA had received nearly 125,000 reports related to surgical stapler issues. Among these reports, there were over 450 deaths, 12,000 serious injuries, and approximately 112,000 device malfunctions. This sharp increase in adverse event reporting highlights the ongoing concerns about the safety and reliability of surgical staplers in the medical community.
Injuries Caused by Surgical Stapler Malfunctions
Injuries caused by malfunctioning internal surgical staplers are often very serious and can have permanent consequences, including death. Some of the more common serious injuries related to surgical stapler malfunctions include:
- Damage to internal organs and tissue
- Internal infections
- Abnormal tissue connections between organs and adjacent tissue
- Uncontrolled internal bleeding
- Death (usually from sepsis or internal bleeding)
Who Manufacturers Surgical Staplers?
In 2024, surgical staplers continue to be produced by several key medical device manufacturers, with two companies dominating the U.S. market. Approximately 80% of surgical staplers used in hospitals in the United States come from Medtronic (which acquired Covidien in 2014) and Ethicon, a subsidiary of Johnson & Johnson.
- Medtronic: Formerly known as Covidien, Medtronic is one of the largest medical device companies globally and supplies a wide range of surgical staplers used for various medical procedures.
- Ethicon: This Johnson & Johnson subsidiary has a long history in the medical device industry, manufacturing advanced stapling devices, including manual and powered staplers designed for both internal and external surgical use.
Other notable manufacturers of surgical staplers in 2024 include:
- Smith & Nephew: A British multinational involved in advanced surgical technologies, including stapling devices.
- Cardica: Specializes in micro-surgical staplers for specific procedures.
- CareFusion: Now part of Becton, Dickinson and Company (BD), provides various surgical instruments including staplers.
- U.S. Surgical: A Medtronic subsidiary that develops a range of surgical instruments, including staplers.
- Reach Surgical: A lesser-known but significant manufacturer in the global market, offering surgical stapling products.
Surgical Stapler Recalls
Over the years there have been a number of major recalls of surgical stapler devices due to manufacturing and/or design defects that caused significant increases in device malfunctions and patient injuries. Nearly all of these recalls have been initiated by the 2 primary manufacturers of surgical staplers, Medtronic and Ethicon.
| Year | Manufacturer | # Recalled | Reason |
|---|---|---|---|
| 2023 | Ethicon | 19,500 | Misfiring malfunction leading to serious injury. |
| 2022 | Medtronic | 11,000 | Misalignment of staples leading to incomplete closures. |
| 2019 | Ethicon | 92,000 | Misfiring malfunction caused staples to go too deep and damage adjacent tissue. |
| 2019 | Medtronic | 3,100,000 | Missing component caused staple misalignment. |
| 2018 | Medtronic | 171,000 | Component defect caused staple misalignment resulting in injuries. |
| 2015 | Ethicon | 6,700 | Staplers were prone to firing blanks, resulting in missing staples in the line. |
| 2013 | Ethicon | 57,000 | Reloading problem causing misfiring and blanks. |
But you do not need to have a recall to have a product defect lawsuit. Certain models of surgical staplers have been implicated in higher rates of malfunction and failure. For instance, devices like Covidien’s Endo GIA stapler with Tri-Staple Technology have been subject to scrutiny for their design and performance. This particular model, like many others, is used in procedures where precision and reliability are critical, such as bariatric surgery or gastrointestinal resections.
Verdicts and Settlements in Surgical Stapler Lawsuits
Over the years, hundreds of injured patients have filed surgical stapler lawsuits and received financial compensation for their injuries. Most of the cases have resulted in confidential settlements so we don’t know how much compensation the plaintiffs received. List below are verdicts in some of the surgical stapler cases that have gone to trial across the country and settlements that were publicly reported.
- Garcia v. Ethicon (New York 2023) $10.5 million: A patient experienced bowel perforations and severe infections due to a defective Ethicon surgical stapler. The jury awarded $10.5 million, including compensatory and punitive damages.
- Carter v. Medtronic (Florida 2022) $4.2 million: A patient faced life-threatening complications during bariatric surgery due to a defective Medtronic stapler. The jury found the design at fault and awarded $4.2 million in damages.
- Johnson v. Covidien (Texas 2021) $3.7 million: A Covidien stapler misfired during gastric surgery, leading to a leak that caused severe complications. The patient was awarded $3.7 million after multiple corrective surgeries.
- Owen v. Medtronic (Kentucky 2020) $2.9 million: During liver surgery, a Medtronic stapler malfunctioned, resulting in major bleeding. The patient received $2.9 million in damages for the complications.
- Ergler v. Ethicon (California 2019) $8 million: A man experienced hernias and ongoing pain after an Ethicon stapler left open staples during surgery. The jury awarded him $8 million for medical costs and suffering.
- Strange v. Covidien (Illinois 2017) $5.5 million: A woman bled to death after a Covidien stapler failed to properly seal during surgery. The husband settled the case for $5.5 million.
- Kuhlman v. Ethicon (California 2016) $79.8 million: A former police officer’s bowel was stapled to her rectal wall, leading to life-threatening sepsis. The jury awarded $79.8 million, though the amount was reduced to $19.6 million on appeal.
- Selpec v. Ethicon (Pennsylvania 2007) $5 million: A patient died from sepsis after an Ethicon stapler malfunctioned during gastric bypass surgery. The jury awarded $5 million in this wrongful death case.
Injured Patients Can Bring Surgical Stapler Lawsuits
Patients who have been injured by malfunctioning surgical staplers can bring a surgical stapler product liability lawsuit against the manufacturer and get financial compensation for their injuries. Ethicon, Medtronic, and other surgical stapler manufacturers have a duty to ensure that their stapler products are safe and effective for their intended use. When a stapler device causes serious injuries, it is most likely the result of a device malfunction, design defect, or manufacturing defect that the manufacturer can be held liable for.
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