Following a warning it issued last month over a defective component for its da Vinci robotic surgical system, Intuitive Surgical has said it is shipping a new version of a defective surgical scissor component.
Intuitive Surgical Inc. previously issued an “urgent medical notification” on the controversial device saying the da Vinci had what CNBC described as “a potential issue” with one of the device’s robotic arms, a problem that could burn patients internally. The defect is with da Vinci’s 8mm EndoWrist Monopolar Curved Scissors, which may develop so-called “micro cracks,” said Intuitive Surgical in the previously released statement.
According to Intuitive Surgical, no injuries had been associated with the arms’ micro crack issue as of its prior announcement; however, six warnings have been issued for the scissors.
Intuitive Surgical is now shipping a revised version of its EndoWrist surgical scissors, according to MassDevice.com. The 8mm EndoWrist Monopolar Curved Scissors are sold as an accessory to the da Vinci robot-assisted surgical system. Intuitive previously explained that the cracks “may create a pathway for electrosurgical energy to leak to tissue during use and potentially cause thermal injury,” according to MassDevice.com, which said that Intuitive Surgical confirmed with it that the revised EndoWrist scissor shipments were underway as of May 31.
In robotic-assisted surgery, a surgeon sits at a console operating several robotic arms that manipulate small tools that are inserted into the patient’s body via tiny incisions. The system also utilizes a small, lighted camera that displays the surgical area in 3-D video. The da Vinci is the only robotic surgery approved by the U.S. Food and Drug Administration (FDA) for soft tissue surgeries, such as prostate and gallbladder removal, hysterectomies, heart repair, stomach reduction, and organ transplantation. Other, similar devices have been approved for neurosurgery and orthopedics.
Personal injury lawsuits allege the da Vinci has caused severe internal injuries, including burns, tears, and other complications, some of which resulted in death or chronic pain and disability. da Vinci lawsuits fault aggressive marketing tactics used by Intuitive to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the robot, coupled with poor physician training on the device, have resulted in serious injuries. Some 70 deaths have been linked to robotic surgical systems since 2009.
Heavily marketed and used in some 400,000 surgeries in 2012 alone, the da Vinci robotic surgery system has been associated with not only a number of deaths and serious injuries, but with and odd accidents. For instance, according to a prior Associated Press (AP) report, in one case, a da Vinci robotic hand gripped and would not release a patient’s bodily tissue during surgery. In another, the da Vinci’s robotic arm repeatedly hit a patient in her face as she was prone on the operating table.