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Innovative medical technology has revolutionized surgery. Patients often benefit from less-invasive procedures and improved outcomes. Unfortunately, nothing is perfect. Products intended to reduce the risk of harm can often cause terrible side-effects and dangerous injuries.
SURGICAL STAPLERS
Surgical staplers from Medtronics, Ethicon, and others cut and seal blood vessels and tissue to close wounds and minimize blood loss. When they fail; patients can bleed, suffer serious injuries, or die. The U.S. Food and Drug Administration (FDA) says surgical staplers can cause “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.”
STRICT RECALL ISSUED
Recently, the FDA recalled over 92,000 surgical staplers made by Ethicon—a division of Johnson & Johnson. The move is a strict Class One Recall—reserved for when a defective medical device may cause serious injury—or even result in death. Ethicon has confirmed serious injuries to patients treated with the recalled devices during gastrointestinal procedures.
The recalled products include:
- Endo-Surgery Curved Intraluminal Stapler with Adjustable Height Staples and
- Endo-Surgery Endoscopic Curved Intraluminal Stapler with Adjustable Height Staples
- Product Codes: CDH21A, CDH25A, CDH29A, CDH33A, ECS21A, ECS25A, ECS29A, ECS33A (Product codes are located on the front of the single unit carton.)
- Manufacturing Dates: March 6, 2018 to March 6, 2019
- Distribution Dates: March 15, 2018 to March 8, 2019
DOCUMENTING PROBLEMS AND FAILURES
The FDA maintains the Manufacturer and User Facility Device Experience (MAUDE) which is a public database widely used by doctors and researchers to track problems and report issues with surgical devices and medical products. The FDA allowed manufacturers of surgical staplers to bypass public disclosure through MAUDE and submit malfunctions to an internal database.
32,000 MALFUNCTIONS, 9,000 SERIOUS INJURIES, 366 DEATHS
According to investigators, the FDA received nearly 10,000 reports of surgical stapler malfunction in 2016 alone. During that time, only 100 reports were disclosed to the public. Between January 2011 and March 2018, the internal database received some 41,000 total reports. That includes over 32,000 malfunctions, 9,000 serious injuries, and 366 deaths previously undisclosed to the public.
YOU HAVE THE RIGHT TO KNOW
There is no way to determine how many patients could have made better-informed decisions regarding their healthcare had these reports been public. If you or a loved one have suffered serious injuries potentially linked to a malfunctioning surgical stapler, contact Freeburn Law today. The time you have to pursue a claim for damages is limited. Do not let time run out.
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If you or a loved one has been seriously injured by a defective product, call Freeburn Law for your free consultation.
When you call, you’ll speak with a leading Harrisburg defective product lawyer for FREE. Freeburn Law will fight hard to seek the justice and the compensation you deserve after an accident. There is no attorney’s fee due up front—and we only get paid after you do.
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The information contained in this page is general in nature and is not intended to be, nor may it be relied upon as legal advice. Freeburn Law does not handle the type of matter discussed on this page, but will refer it to lawyers and/or law firms who do handle these types of matters.
