From January 1, 2011, to March 31, 2018, the FDA received more than 41,000 individual medical device reports for surgical staplers and staples used internally during surgery. Of these, hundreds were deaths and thousands were serious injuries and malfunctions.
When are staplers and staples used?
Surgical staplers cut and seal blood vessels and tissue, often during minimally invasive surgery. They are used in situations where body parts are either hard to reach or the speed of closure is important. Common procedures may include gastrointestinal, gynecologic, colorectal, vascular, and thoracic surgeries. These types of surgeries can be categorized as:
- Resections – Removing part of an organ
- Tran-sections – Cutting through organs and tissues
- Anastomoses – Creating connections between structures
Malfunctions and Types of Injuries
Some of the problems reported include the opening of the staple line or malformation of staples, misfiring, difficulty in firing, failure of the stapler to fire the staple, and misapplied staples. These events can be catastrophic to patients and cause:
- Intestinal dysfunction – uncontrolled diarrhea, constipation
- Occlusion of the gastrointestinal tract
- Organ damage
- Severe pain
- Bleeding and extensive blood loss
Class I Recall
The FDA labeled a recent recall of circular staplers by Johnson & Johnson (J&J) unit Ethicon as Class I, the strictest form of recall issued. The recall involved a total of 92,496 Endo-Surgery Curved and Endo-Surgery Endoscopic Curved Intraluminal Staplers. The FDA warned that the use of these staplers could lead to serious patient harm or death.
Let Us Help You
Have you or a loved one been hurt by the misuse or malfunction of a surgical stapler? If you have been injured during surgery, and believe that you may want to file a surgical stapler lawsuit, contact us immediately for a free legal evaluation.