FDA Announces J & J Surgical Stapler Recall
On October 26, 2012, the U. S. Food and Drug Administration announced a surgical stapler recall of Johnson & Johnson Ethicon Endo-Surgery Circular Stapler medical devices. These surgical stapler devices are used in the surgical treatment of prolapse and hemorrhoids, or in other applications where circular or semicircular stapling of anorectal tissue (i.e. the structure of the anus and rectum) is needed.
The surgical stapler recall of these medical devices was based on the difficulty users have firing the surgery stapler devices, resulting in incomplete firing stroke and incomplete staple formation.
The Wall Street Journal reported that Johnson & Johnson recalled more than 157,000 surgical stapler devices and accessories used in hemorrhoids treatment procedures due to potential malfunctions that pose a serious safety risk.
Injuries Caused Resulted in Surgical Stapler Recall
The FDA surgical stapler recall was based on the injuries that could be caused by this medical device. Failure to complete the firing stroke of the stapler can result in:
- Severe pain
- Sphincter dysfunction
- Rectal wall damage
- Sepsis (blood infection)
- Bleeding
- Occlusion (blockage) of the rectal canal.
Failure to complete the firing stroke can also result in poor staple formation, dehiscence of the rectal wall staple line (a surgical complication in which a wound breaks open along surgical suture), and bleeding.
Maryland Defective Medical Device Attorney
If you or a loved one has suffered injury as a result of a defective medical device, including a surgical stapler, you need an experienced Maryland medical device lawyer to fight for you. Medical malpractice attorney Jonathan Scott Smith has been helping injured people for more than 30 years. He has handled successfully medical malpractice cases, including cases involving defective medical devices.
Mr. Smith’s extensive trial experience — and track record of successful Past Results — has earned him the recognition of his peers, with an AV® Preeminent™* Peer Review Rating in the Martindale-Hubbell peer review rating process, and a 10.0 Superb AVVO rating. These are the highest ratings possible for legal skill, ethical practice, a lawyer’s years in practice, disciplinary history, professional achievements and industry recognition.
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If you or a loved one has suffered a serious injury because of a defective medical device, including one subject to a surgical stapler recall, contact us.