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Da Vinci Robot

Advances in robotic surgery have made it possible for surgeons to operate using far smaller incisions than were previously possible.

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The benefit, obviously, is that patients will heal more quickly, and with less blood loss than is possible using traditional surgical methods. It sounds good in theory, but in practice, robotic surgery is not without complications.

The Da Vinci Robot

One such development in robotic surgery is the Da Vinci Robot, manufactured by Intuitive Surgical, Inc. The company represents the Da Vinci Robot as the wave of the future, and in fact, thousands of surgeries have been performed using the device. There are now more than 2,500 Da Vinci Robots in hospitals nationwide.

The Problem

Indisputably, a number of people have benefited from the Da Vinci technology. However, there have been a number of lawsuits filed on the behalf of patients and their families who claim that the robot has caused permanent, preventable harm.

Dr. Francois Blaudeau, a gynecologist and Da Vinci Robot attorney, attributes this harm to electrical currents leaking out of the robot during the surgical process. The leakage causes sparks, or “arcing,” and can cause post-operative complications including:

  • Perforated intestines
  • Vaginal injuries
  • Prostate injuries
  • Infections
  • Painful abscesses

These complications can cause permanent disability.

Da Vinci Robot attorneys have filed lawsuits claiming that Da Vinci:

  • Manufactured a product that was defective
  • Failed to properly test the product
  • Failed to warn people about the possible dangers
  • Failed to properly train surgeons and hospital
  • Failed to monitor the product effectively and report complications
  • Knowingly sold an unsafe product

Intuitive has, of course, maintained that their product is perfectly safe when used correctly. However, within two years of launching the product, they introduced attachments designed to reduce arcing, and instructed doctors to be certain to use them.

Further, the US FDA (Food and Drug Administration) issued a warning letter to Intuitive, listing four violations that they had identified regarding the Da Vinci. Each violation involved providing misleading information, and failing to inform the FDA when equipment was known to be faulty.

The Medical Perspective

Doctors do not automatically recommend Da Vinci surgery. In fact, between January of 2010 and December of 2011, more than 134 doctors complained to Intuitive about problems with the Da Vinci Robot. 83 of them filed FDA reports. The main problem was identified as “tip cover issues” that caused arcing. Intuitive maintained that the tip covers were just fine, but then in 2011, they designed new tip covers, and instructed hospitals and doctors to use them immediately. Da Vinci Robot attorneys are understandably puzzled as to why something that caused no harm had to be replaced and used “immediately.”

Questionable Marketing

Intuitive has also been accused by litigants of over-aggressive marketing, and encouraging doctors to use the Da Vinci Robot even in the absence of proper training. One company representative told doctors at a Montana Hospital that a surgeon should be able to perform Da Vinci Surgery unassisted in fewer than five supervised sessions. This flies in the face of a study by Dr. Sherry Glied and Dr. Gabriel Barbash that suggests the actual figure is more like 150-250 procedures before a surgeon should proceed unassisted.

Contact an Attorney

If you or a loved one has been harmed during surgery using a Da Vinci Robot, an attorney who specializes in such cases can work with you to determine the parties responsible. This would of course include the manufacturer, and also potentially the surgeon, sales personnel, testing labs, and anyone else involved in the process of delivering the Da Vinci surgery to you or your loved one.

 

Sources:

http://www.davincisurgery.com/

http://www.lawyersandsettlements.com/lawsuit/da-Vinci-robot.html#.VZVmyhtViko

 

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