FDA Warns Of Surgical Stapler Risks

Chicago med mal attorneys

FDA Releases Statement on Dangers of Staplers Used in Common Surgeries

Everyday medical devices such as surgical staplers can be beneficial tools and aid procedures in both time and recovery when used correctly. But after the U.S. Food and Drug Administration (FDA) reviewed an increasing number of reports in line with the use of these common devices, the need to update safety recommendations and remind medical providers of the risks associated with the devices’ safety became correspondingly apparent.

“As part of our public health mission, it is important that we communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices.”

-William Maisel, M.D., M.P.H.,

Chief Medical Officer, FDA’s Center for Devices and Radiological Health

March 8, 2019

As the statement by the FDA and Chief Medical Officer Maisel continued, the agency’s analysis of surgical staplers and staples for internal use reports shows that from January 1, 2011 to March 31, 2018, the FDA received:

  • 41,000+ individual medical device reports (MDR)
  • 32,000+ stapler or staple malfunctions
  • 9,000+ serious injuries
  • Notice of 366 related deaths

The FDA says they will continue to evaluate the MDRs filed with the agency for these devices. In the meantime, it is important for patients to understand the risks imposed by these tools when used in their surgery.

Common Surgery Stapler Related Injuries

Many surgical procedures require the use of surgical staplers to shorten procedure time compared to manual suturing. Physicians who commonly use these devices may work in gastrointestinal, gynecologic, and thoracic surgeries to remove part of an organ but also to cut through tissues, and to create connections between structures.

Commonly reported problems in the current MDR review included:

  • an opening of the staple line
  • malformation of staples, misfiring
  • difficulty in firing
  • failure of the stapler to fire
  • misapplied staples (e.g., user applying staples to the wrong tissue or applying staples of the wrong size to the tissue)

The FDA says if a stapler is misused or a staple malfunctions, a patient may require exhaustive unplanned surgical interventions, which may lead to other painful complications such as bleeding, sepsis, tearing, increased risk of cancer recurrence, and death.

Suspect a Surgery Mistake?

Medical errors are now the third leading cause of death and Johns Hopkins patient safety experts says are responsible for more than 250,000 deaths per year in the U.S. If you were injured by a mistake made by a doctor using a medical device, you may need to take legal action before you can begin a full recovery.

  • Speak with an attorney as soon as possible.
  • Keep all information pertaining to the injury, including a journal of any pain and suffering.
  • Victims generally have about two years to file a claim against a doctor or hospital.
  • Your attorney will review and evaluate your situation to determine how to proceed.

In some cases, you may need to file a lawsuit to recover any losses caused by the injury. You may have expended a great deal of money for medical treatment to resolve the mistake made by the doctor. You may also have lost time from work and may have suffered a great deal of pain. These are items that may be recovered in a lawsuit.

Contact a Medical Malpractice Lawyer in Chicago

If you have experienced medical malpractice in Chicago or throughout Illinois, take action and immediately contact Levin & Perconti online or call us at 877-374-1417 or 312-332-2872. A free consultation with an experienced Chicago medical malpractice lawyer can only help you during the recovery process.

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