Surgical Stapler Lawsuit

About Surgical Staplers

Surgical staplers for internal use are medical devices used in a variety of routine surgeries and are designed to cut vessels and tissues, then rapidly seal them. Surgical staplers may be used in gastrointestinal, gynecologic, thoracic, and many other surgeries [1].

Examples of uses are:

  • Removing part of an organ (resection)
  • Cutting through organs and tissues (transection)
  • Creating connections between structures (anastomoses)

Surgical Staplers Injury Data Presented by FDA

From January 1st, 2011 to March 31st, 2018, all medical device reports for surgical staplers and implantable staples include the following [1]:

  • Deaths: 366
  • Injuries: Over 9,000
  • Malfunctions: Over 32,000

The surgical staplers being investigated are for internal use, not the external staplers designed to close skin incisions.

There are various manufacturers of internal surgical staplers. Two brands that lead the market are:

  • Covidien (Medtronic): creates Endo GIA, DST Series GIA; MultiFire GIA; Signia; DST Series GIA and others
  • Ethicon (Johnson & Johnson): Endopath; Echelon; Contour and others

There are three main categories of these staplers: linear, circular, and powered. Additionally, each manufacturer has many models in each category.

About the Defect

In a letter distributed to health care providers from the FDA, the FDA summarized that the most commonly reported issues include [2]:

  • Opening of the staple line or malformation of staples
  • Misfiring
  • Difficulty in firing
  • Failure of the stapler to fire the staple
  • Misapplied staples (i.e., applying staples of the wrong size to the tissue, or, applying staples to the wrong tissue)

Injury Types Cited by FDA

As a result of the above malfunctions, thousands of reports reveal the following injuries, according to the FDA [1]:

  • Fistula formation
  • Bleeding
  • Tearing of the internal tissues/organs
  • Anastomotic leak (a leak between two structures that were surgically connected)
  • Increased risk of cancer occurrence
  • Sepsis
  • Death

The failure of the staple is considered to be a failure of the stapler, as one cannot be separated from the other.

Surgical Stapler Injury – We can help

Martin, Harding & Mazzotti, LLP is now accepting cases on behalf of those who have undergone internal surgery where a surgical stapler was used and have experienced the following as a result of the stapler malfunction, or misfire:

  • Fistula formation
  • Catastrophic bleeding
  • Tearing of the internal tissues/organs
  • Bowel leakage
  • Sepsis
  • Death

If you or a loved one have experienced any of the above symptoms, you may be entitled to compensation. Contact the trusted legal counsel at Martin, Harding & Mazzotti, LLP, for a free no obligation consultation. Click, Chat or Call 1(800) 529-1010 24/7 for a free case evaluation.

Act Now

Every state has a window of time known as a statute of limitations within which a lawsuit for injuries suffered must be commenced. If that period expires, an injured person will be prevented from bringing a claim against those who may be responsible. The only way to determine the time in which you have to file a claim is to review the individual facts pertaining to your potential claim.

Every claim is different with its own circumstances and considerations, but the important thing is to act now. Our experienced and dedicated defective medical device attorneys are here for you, 24/7.

Call us for a free consultation to determine a course of action that is in your best interest.