Defective Medical Device Litigation Attorney’s | Information on Ethicon Surgical Stapler
Surgical staples are commonplace in many medical practices as they are used for a variety of different surgeries. These staplers operate in a similar fashion to your common stapler and are primarily used to close wounds and/or surgical openings. Ethicon, which is a subsidiary of Johnson & Johnson, is the primary manufacturer of various surgical stapler products including the Echelon and Endo-Surgery models.
Externally, they are primarily used in high tension area’s such as the scalp or the core of the body. Additionally, they also can be used internally as well on internal tissue. Most commonly, they are used in gastrointestinal, gynecological, and thoracic surgeries. Similar to your common stapler problems though, the surgical stapler can potentially misfire, jam or in some cases fail to completely close the staple.
Surgical Stapler Malfunction
Unfortunately, issues resulting from malfunctioning surgical staples have been occurring for many years leading to serious injuries and even death. Some of the most common injuries are excessive bleeding, tissue damage, organ damage, infection, fistula and recurring cancer cells. A majority of the injuries and deaths are a result one of the following issues:
- Defective manufacturing
- Lack of warning to consumers about associated risk
- Defective design of the stapler
- Malfunction of the device including misfire, jamming, etc
Recalls of Surgical Staplers
In 2013, Ethicon staplers were found to have a reloading issue which resulted in the device no longer being able to staple. This was the first of multiple recalls that would occur. Since then, the FDA has continuously been monitoring existing and new devices. Most recently, the FDA initiated another recall in late 2019.
FDA Surgical Stapler Recalls
- Ethicon Echelon 60mm staplers
- Ethicon Endopath staplers
- Ethicon Echelon Flex staplers
- Ethicon Endo-Surgery Curved staplers
- Medtronic Endo GIA Auto Suture staplers
- Medtronic Endo GIA Articulating Reloads staplers
Hidden Database Filled with Reports of Stapler Malfunction
Recently, an investigation by Kaiser Health News discovered that manufacturers were keeping surgical stapler malfunction reports in an obscure non-public database. This resulted in doctors and other medical professionals not having access to the majority of the malfunction reports. If they would search for safety information on these devices, they would only see a handful of reports as opposed to the 110,000 that were actually sent in. For example, in 2016 there were only 84 stapler malfunction reports openly submitted while there was actually 10,000 more malfunction reports that were hidden in this private database.
Lawsuits Against Surgical Stapler Manufacturers
As of late, an increasing number of patients have come forward alleging that the surgical staples used lead to a myriad of issues including severe injuries, prolonged surgery or the need for additional surgical procedures. Victims of surgical stapler malfunctions have already been filing lawsuits with settlements and verdicts ranging from $5 million to $80 million.
If you or a loved one has endured suffering or serious complications after undergoing surgery with the use of surgical staples, call 855-566-3752 or contact us online today for a free case evaluation. We are here to help you!
