Surgical Stapler Injury
Surgical staplers are used in many different kinds of surgeries. Moreover, the instances of the use of surgical staplers are increasing. These devices are used to close openings in the body, such as a wound caused by trauma or a surgical incision, replacing more traditional stitching and suturing. The operate in a manner very similar to a conventional stapler one could fine in an office or around the home.
Sometimes, however, the staplers can fail. Just as the office stapler will occasionally jam, or a staple will not close properly after puncturing the paper, a surgical stapler can suffer malfunction. Yet where the office stapler can simply be reloaded, the stakes are much higher when surgery is being performed around vital organs. When there is a malfunction affecting sensitive tissues and organs, such as the gastrointestinal tract, heart, lungs, or kidneys, the consequences can be devastating. Complications from a surgical stapler failure can include death, sepsis, internal bleeding, the need for permanent ostomy bag, damage to internal organs, additional surgeries, and life-long nutritional and digestive issues.
Misfired staples can embed in tissues or organs, causing serious damage. Staples that fail to close completely can allow bacteria and other foreign matter can invade the wound and cause sepsis or infection. Jagged staple ends can lacerate internal organs and organ systems can hemorrhage, causing the patient to bleed internally and sustain organ damage. Stapler failures can take days to identify and some of the complications can be irreversible.
The FDA brought the risks of surgical staplers to the attention of healthcare practitioners through correspondence dated March 8, 2019. It reported that over the last 8 years, there were 109,997 reports of surgical stapler malfunctions, including 11,181 serious injuries and 412 deaths. The FDA also announced potentially upgrading surgical staplers from a Class I medical device to a Class II medical device, and forcing manufacturers to prove the safety and effectiveness of surgical staplers through performance testing and usability testing.
If you or a loved one has suffered injury because of a surgical staple failure, contact the experienced attorneys at Neumann Law Group for a free consultation today.