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Surgical Staplers and Staples

What are Surgical Staplers?

Surgical staplers are used to connect blood vessels and tissues during surgery and are considered a faster, easier alternative to nylon sutures, but at what cost to the patient? When these devices misfire during surgery, or completely fail to fire, patients can bleed profusely, causing additional complications and, sometimes, catastrophic consequences.

After an FDA investigation revealed over 109,000 incidents involving surgical staplers—including 366 deaths, 9,000 serious injuries, and 32,000 malfunctions—the FDA sent a letter to health care providers advising its reevaluation of the safety of surgical staplers. The FDA also stated its intention to reclassify the devices for tighter control, including more thorough testing of various mechanical features.

FDA RECALL: The Ethicon Endo Curved Intraluminal Stapler was RECALLED by the FDA in May of 2019.

In May of 2019, the FDA issued a recall on both the Ethicon Endo Curved Intraluminal Stapler and the Ethicon Endoscopic Curved Intraluminal Stapler, both 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—March 6, 2019
  • Distribution Dates: March 15, 2018—March8, 2019

These staplers were used for surgeries within the gastrointestinal tract (esophagus, stomach, intestines, and bowel/rectum) and were found to “misfire,” meaning the circular staples failed to close completely leaving the wound susceptible to tearing, infection, and reopening.

This stapler may have been used in any type of gastrointestinal surgery including those for colorectal cancer, bariatric surgeries, endo related surgeries, gynecological surgeries, urological surgeries, and thoracic surgeries.

Serious complications and injuries following an Ethicon Stapler malfunction include leaking from the closure site (anastomotic leakage), tearing of internal organs, bleeding from internal organs, sepsis, additional surgery and re-closure, permanent ostomy “bag,” lifelong nutritional and digestive issues, fistula development, or even death.

If you or a loved one suffered serious complications, injuries, or death following the use of an Ethicon Stapler during your gastrointestinal surgery, we are here to help.

FDA RECALL: The Covidien Signa Tri-Staple 2.0 was RECALLED by the FDA in June of 2019.
How do I know if a recalled surgical stapler was used in my surgery?

If you suspect that a recalled or defective device—including surgical staples and staplers—was used during your surgery, you may ask the hospital or surgeon what type of stapler was used or request a copy of your medical records from the hospital or surgery center where your surgery was performed. You can do this either in person or through a written request mailed to the records department asking for a full copy of your medical and surgical records.

When making your request, you should specify that you want the full surgical records to be included. Many times, hospitals will only include the narrative notes or summary of the surgical procedure instead of the full set of documents.

Keep in mind that it is reasonable for the hospital to charge you approximately $25-$50 for a copy of your records depending on the number of pages included in your records. The hospital also has up to 15 days to provide the records to you from the day of the request.

Once you receive your medical records, the type of stapler used in your surgery will be listed on the “sticker sheet” or inventory list included with your surgical records.

For a step-by-step how-to on requesting your medical records please download this form: FORM(medical device specific).

How We Can Help

Our attorneys are currently evaluating and investigating claims on behalf of patients severely injured or killed by defective or misused surgical staples and staplers during gastrointestinal and abdominal type surgeries. If you have been injured during surgery, and believe that you qualify for a surgical stapler lawsuit please contact us immediately.

In many cases, filing a lawsuit is the only way to recover money that is lost from hospital expenses, lost wages, and funeral costs. In other cases, people file lawsuits because they want to make a difference and prevent others from suffering through the same horrors as they have.

Van Wey, Metzler & Williams Can Help, No Matter Where You Live.

To discuss the specifics of your potential lawsuit in a free and confidential consultation, contact us today. You may call us at 1 (800) 489-5082.

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