Surgical Stapler Injury

Overview

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.

Medical Procedures

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.

FDA Letter

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.