FDA to Investigate Safety of da Vinci Surgical System
An Urgent Medical Device Notification has been issued because of severe injuries occurring during surgeries using the da Vinci Surgical Robot.
The da Vinci Surgical System is a set of instruments that allows a surgeon to view the patient’s anatomy on a computer screen and perform operations through the hands and arms of a medical robot. The robotic system is used throughout the country, including five surgical facilities in the Chattanooga area. The robot is frequently used to perform complex surgeries such as gynecological, urological, colorectal, cardiac, thoracic, and head and neck.
The da Vinci surgical robot is supposed to benefit patients by allowing for a smaller incision, decrease blood loss and improve recovery time. However, there are serious and potentially fatal dangers associated with the device for which patients need to be aware.
In 2013, the makers of the da Vinci (Intuitive Surgical) issued an “Urgent Medical Device Notification,” stating that it “has identified a potential issue with certain versions of the Hot ShearsTM Monopolar Curved Scissors (MCS) Instrument.” The danger is microscopic cracks in the arm allowing electricity to arc out and damage surrounding organs. For example, during a routine prostatectomy, the bladder could be inadvertently burned by electricity coming through the infinitesimal crack in the MCS casing.
Since 2007, the FDA has received thousands of reports involving problems with the robotic system, including an alarming 89 patients’ deaths. Many of the non-fatal reports contain disturbing malfunctions, like the time the system failed to respond to commands to let go of tissue it was holding and had to be shut down in order to free the patient. There have also been reports of more horrific complications, such as the woman whose intestines fell out of her vagina five weeks post-hysterectomy due to an improperly closed hole where her cervix had been.
The FDA is now looking into whether the problems linked to the da Vinci system have truly increased, whether reporting has improved due to doctors being more aware of and willing to report problems due to increased use of the system, or whether the seemingly increased problems are due solely to increased use. Additionally, the instructions and training provided to the doctors using the robot may have been extremely insufficient.
If you or someone close to you has been injured during, or suffered complications after a surgery in which the da Vinci Surgical System was used, please contact Massey & Associates immediately.”
