Lawsuit Alleges da Vinci Surgical Robot Caused Death After Hysterectomy

The father of a New York City woman has filed a wrongful death lawsuit against Intuitive Surgical, Inc., alleging that his daughter died from injuries sustained following the use of a da Vinci robot during a hysterectomy.

The case was filed by Gilmore McCalla in the U.S. District Court for the Southern District of New York on April 4, alleging that the death of his daughter, Kimberly McCalla, was caused by problems with the device used during her robotic surgery.

The da Vinci surgical robot is a complex machine that features four remote controlled arms and a camera, allowing surgeons to operate through a small incision with a joystick-like control. The device is promoted as allowing for less invasive surgery and shorter recovery times, but there have been a large number of serious and fatal complications and problems associated with the da Vinci surgical robot.

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According to the complaint, Kimberly McCalla was admitted to Montefiore Medical Center on August 12, 2010, for performance of a hysterectomy. As a result the procedure, she suffered a burn of the right external iliac artery, which caused it to pump blood directly into her body cavity. Following three emergency surgeries, Kimberly McCalla died on August 25.

The da Vinci surgical robot lawsuit alleges that the manufacturer, Intuitive Surgical, failed to adequately research the device or warn patients and the medical community that use of the robot carries a susbtantial risk of complications and injuries, including burns, tears, dehiscences, bleeding, hematomas, sepsis and fistulas.

The complaint indicates that the da Vinci surgical robot is defective, in that it relies on use of monopolar energy to cut, burn and cauterize tissue, although safer methds are available that would reduce the risk of complications. The device also has inadequate insulation for the arms, according to allegations raised, allowing electrical current to pass into the tissue outside of the operative field.

There have been a number of complaints and incidents surrounding the use of the da Vinci robot, most often regarding burns and tears to internal organs and blood vessels, according to McCalla’s complaint. The injuries do not always appear immediately during the actual operation, which can further increase the seriousness of the complications.

The use of the da Vinci surgery robot is more expensive than traditional surgical procedures, and there has been debate among the medical community about whether there are any health benefits. Both the American College of Obstetricians and Gynecologists and the Kaiser Foundation have raised questions over the widespread adoption of the robot at many hospitals.

In the complaint, McCalla indicates that Intuitive Surgical has sold the da Vinci robot through a program designed to intimidate hospitals and physicians, by making them believe they will lose business to competitors if they do not have the technology. They also marketed on the internet directly to consumers, seeking to create demand among patients for the device.

In addition to failing to adequately research the device, Intuitive Surgical has allegedly failed to reveal through publications or reports to the FDA the true extent of complications and injuries that have occurred. The complaint also alleges that the company has suppressed reports of complications and performance errors.

The adequacy of training provided for surgeons on use of the complex surgical robot is also attacked in the lawsuit, and has been increasingly questioned in a number of media reports in recent years. While some research suggests that hundreds of cases may be necessary before a surgeon becomes proficient at use of the device, Intuitive Surgical only provides hospitals with a two-day course operating on human and pig cadavers, followed by four live cases supervised by a proctor.

According to McCalla’s complaint, Intuitive Surgical “does not adequately train physicians nor proctor them properly on the use of its device, thereby inducing them to cause complications and injuries which would be avoided in the hands of properly trained physicians.”

Photo courtesy of http://en.wikipedia.org/wiki/User:Nimur / CC by 3.0

1 Comments

  • bethSeptember 3, 2012 at 7:30 pm

    Does anybody out there know if the initial cut for surgery for endometriosis is made by the robot or by the physician. If they are using the da Vinci robot, wouldn't it do everything from beginning to end?

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