Wrongful death and personal injury lawsuits are being filed against Intuitive Surgical, Inc., the maker of the da Vinci Robotic system. These lawsuits are alleging that patients are being injured following the use of a da Vinci robot during a hysterectomy and other surgeries.
Recently a 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.
What is the da Vinci Robotic System?
The da Vinci surgical robot is a medical surgical 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 touted as 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.
da Vinci Surgical Robot Background
Intuitive Surgical received clearance from the U.S. Food & Drug Administration (FDA) to market the da Vinci Surgical Robot in 2000.
The robot, which can cost hospitals as much as $2 million, is controlled remotely from a console, while the robot’s arms are placed into the patient for burning away tissue in order to remove the diseased organs.
Da Vinci Lawsuits
The da Vinci surgical robot lawsuits allege 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 substantial risk of complications and injuries, including burns, tears, dehiscence, bleeding, hematomas, sepsis and fistulas.
The complaints claim that the Da Vinci surgical robot is defective, that relies on use of monopolar energy to cut, burn and cauterize tissue, although safer methods are available that would reduce the risk of complications.
The device also has inadequate insulation for the arms, allowing electrical current to pass into the tissue outside of the operative field. The injuries do not always appear immediately during the actual operation, which can further increase the seriousness of the complications.
Da Vinci 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 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.
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.