FDA Approves Intuitive Surgical’s Fixes to da Vinci Surgical System

The U.S. Food and Drug Administration (FDA) has recently declared that Intuitive Surgical adequately addressed concerns raised about the da Vinci robot surgical system.

In a letter dated April 25, an FDA compliance officer informed Intuitive that “the company’s corrective actions in response to the 2013 warning letter appeared to pass muster.”

The FDA had accused the company of failing to report design complications, which had caused accidental electric burns to patients. While the FDA gave the company its approval, many medical experts still question the safety of the product, as well as other robotic surgical systems.

A recent study published in the online issue of Journal of Clinical Oncology found no indication of robotic surgical systems being superior to traditional surgeons. The study stated that the robotic surgery held the same risks and room for error as human surgeons in terms of complication rates, readmission rates, and rates of additional cancer treatments.

While the researchers said that the surgical systems carried a lower risk of blood transfusions and slightly shorter hospital stays, these benefits do not equate to the risks these devices carry, or their large fees. Recently, hospitals have been accused of exaggerating benefits of the robotic surgical systems while not adequately describing the risks.

Robotic surgical systems have also been featured in FierceHealthIT’s list of five overrated, overpriced healthcare technological services. In fall 2013, the ECRI Institute ranked robotic surgical systems number nine on its Top 10 health technology hazards list, pointing out there are no recognized credentials that are required to use a robotic surgical system.

The da Vinci surgical system is one of the only robotic surgical systems approved by the FDA. Insurers, medical organizations, and some healthcare providers have recently started to question the costs and risk of injuries by using the da Vinci, or any robotic surgical system, for a procedure.

The growth of gynecologic, prostate, and other small-incision surgeries has made the Da Vinci’s popularity rise, but also has led injury reports to come to light. The recent bad publicity has led to sales drop of the da Vinci surgical system.

Overview of da Vinci Surgical Complications

As of October 2013, Intuitive Surgical had faced at least 50 da Vinci robotic surgical system lawsuits, accusing the company of selling and marketing a defective product. Plaintiffs have stated that the company had failed to adequately warn them and their doctors about the risks the da Vinci systems carried.

The most common injuries that have been reported from using da Vinci surgical system include, but not limited to:

• Cuts or nicks to arteries or organs
• Excessive Bleeding
• Loss of any bodily functions
• Sepsis
• Punctured blood vessels, organs or arteries
• Severe bowel injuries
• Punctured or cut uterus
• Vaginal cuff dehiscence (reopening of the incision made to remove the uterus and cervix during a hysterectomy)
• Revision surgery to repair damage
• Wrongful death

Join a Free da Vinci Robot Class Action Lawsuit Investigation

If you or a loved one were injured by da Vinci robotic surgery complications, you may have a legal claim. See if you qualify to pursue compensation and join a free da Vinci robot class action lawsuit investigation by submitting your information for a free case evaluation:

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