A surgical stapler is a medical device used by doctors to close wounds during surgery. The two ways commonly used to close an open wound during a surgery is to use a suture or surgical stapler. A surgical stapler closes wounds using medical staples. Defective surgical stapler equipment can lead to further surgeries and cause patients further injuries. Even careful doctors can misfire a surgical stapler. Sometimes, it’s a defective surgical stapler that causes injury. The U.S. Food and Drug Administration (FDA) claims that from January 2011 – March 2018, the FDA received over 109,997 medical device reports on surgical stapler malfunctions.
Additionally, the FDA reported 412 deaths and 11,181 severe injuries related to surgical stapler complications. If you have experienced medical complications following a surgery that involved surgical staples, contact us today.
Surgical staplers are commonly used to close wounds during Gastric Bypass surgery.
Gastric bypass is a medical procedure that divides a patient’s stomach into two different sections. One section is a very small upper pouch and the other portion is the remainder of the stomach. The small intestine is attached to the larger section of the stomach. This connection allows the upper pouch to connect to the small intestine to assist with digestion. Following gastric bypass, a patient will eat less because the upper section of their stomach becomes full with less food. As a result, a patient now has control of their appetite and weight stability.
A surgical stapler device allows surgeons to close incisions made during the gastric bypass procedure. Gastric bypass stomach separation cuts are often too large for stitches, however, sometime surgical staples don’t perform either. Common complaints about surgical staplers include: fails to form correct staples, misfire, fire improperly, staples come loose, fail to keep the incision closed.
Surgical Stapler Risks
The FDA recently reported that between 2011-2018, there were 109,997 reports of surgical stapler malfunctions. Specifically, 11,181 serious injuries and 412 deaths. More than 4 serious injuries per day are caused by surgical stapler malfunctions, equivalent to approximately one death per week.
The manufacturers of surgical staplers have known about surgical stapler malfunctions and failures for years. Surgical stapler manufacturers have issued numerous recalls. Recently, in May 2019, Ethicon issued a Class I recall of 92,496 units. Since 2014, over 2 million surgical stapler units were recalled, across all manufacturers.
While surgical stapler manufacturers knew of the stapler malfunctions and problems, it failed to warn doctors and hospitals. Kaiser Health News discovered that stapler malfunction reports received by surgical stapler manufacturers were kept in a non-public database. As a result, when a doctor or a hospital researched safety information about surgical stapler devices, doctors would only see a small fraction of malfunction reports. Unlike the 109,997 patient reports that were actually submitted, in 2016, only 84 stapler injuries or malfunctions were openly submitted. Compared to nearly 10,000 malfunction reports retrieved in the hidden database.
The FDA recently notified the medical industry of the risks of injuries caused by surgical staplers. On March 8, 2019, the FDA submitted a letter and announced that the FDA considered making an upgrade of surgical staplers from a Class I medical device to a Class II medical device. As a result, a classification upgrade will require manufacturers to prove the safety and effectiveness of surgical stapler device, and will require testing for performance and usability to determine safety.
Makers Of Surgical Staplers
Surgical staplers are common in different kinds of surgeries and surgical stapler use is increasing. American hospitals use surgical staplers primarily manufactured by either Ethicon (a subsidiary of Johnson & Johnson) or Covidien (a subsidiary of Medtronic). Consumers have already filed claims in Ethicon stapler lawsuits.
Surgical staplers operate similarly to a home, office, or construction staplers. Unlike other staplers, surgical staplers should be medically tested and approved for use during surgery. Surgical staples are used as an alternative to hand-stitching or suturing surgical incisions and openings.
Similar to home and office staplers, surgical staplers can jam, misfire, or fail to close staples. Unlike a consumer stapler, when a surgical stapler misfires or fails to close a staple it occurs near sensitive tissues and organs, causing further issues to the patient’s gastrointestinal tract, heart, lungs, or kidneys, and the consequences may be devastating. Surgical stapler malfunctions and failures may lead to death, sepsis, internal bleeding, the need for permanent ostomy “bag,” damage to internal organs, additional surgeries, and life-long nutritional and digestive issues. As a result, a patient may never be the same.
Surgical Stapler Consequences
Surgical staplers have a unique ability to harm patients. Misfired staples pose a unique threat because a misfired staple can embed in tissues or organs that were not intended to be stapled. If a staple fails to close or fails to completely seal a wound, bacteria can invade the wound, causing sepsis or infection. Moreover, internal organs systems can hemorrhage causing internal bleeding and damage. Surgical stapler failures may even occur multiple times in a row before doctor correction. Some surgical stapler injuries may be irreversible. In some surgeries where surgical staplers malfunction, an additional corrective surgery is required to fix the previous malfunction. Unfortunately, the damage and injury to a consumer from a pervious stapler malfunction may have already caused irreversible damage.
Common Surgical Stapler Injuries
Some injuries may include:
- Infection at the staple site
- Infection at the incision site
- Injuries that require revision surgeries.
- Internal bleeding
- Septic shock, which is an infection which reaches the bloodstream and travels to major organs.
- Stomach acid leaking from areas that reopen after the procedure
Frequently Asked Questions
What types of surgical staplers cause safety concerns?
Common surgical stapler safety concerns, include: defective surgical staples, operator error, misfiring, and malformed staples. Presently, surgical stapler injuries sustained due to operator error are leading to an influx in medical malpractice claims.
What types of injuries do surgical stapler malfunctions cause?
The FDA claims that surgical stapler malfunction can cause many injuries, including:
- Internal tissue damage
- Organ perforation
- Increased risk of cancer recurrence
- Wrongful death
News & Resources
Surgical Staple Injury | Surgical Stapler Malfunction | https://khn.org/news/more-than-half-of-surgical-stapler-malfunctions-went-to-hidden-fda-database/