May 13, 2013 — Intuitive Surgical, the manufacturer of the Da Vinci Surgical Robot, issued an “Urgent Medical Device Notification” to doctors and hospitals on May 8. They warned about burns and electrocutions caused by the EndoWrist Monopolar Curved Scissors (or “Hot Shears”), an instrument used to burn, cauterize, and cut tissue during robotic surgery. The problem is that doctors may fail to notice “micro-cracks” in the scissors’ insulation, which may cause electricity to arc and burn tissue outside the surgical area.
Although Intuitive said that only one patient injury has been linked to the “micro-cracks,” the FDA has received thousands of unexplained reports of burns, electrocutions, and patient injuries in the last few years. Intuitive is also facing several lawsuits alleging that defective insulation on the Monopolar Curved Scissors can cause electrical burns.
One such lawsuit was filed in July 2012 by Elisa Rister and her husband in the U.S. District Court for the Northern District of California. According to her complaint, she chose to have a hysterectomy with the Da Vinci robot because she was told that it would provide a better outcome, less pain, and faster healing time. Instead, she suffered devastating long-term complications when the robot damaged her ureter. According to the lawsuit:
“The device is defective in that it relies on the use of monopolar energy to cut, burn and cauterize tissue, whereas safer methods are available such as bipolar energy and ultrasonic energy … The device has inadequate insulation for its arms thereby allowing electrical current to pass into tissue … [Insulation] becomes torn and worn in places, without the awareness of the physician.”
Intuitive has been receiving complaints about the Monopolar Curved Scissors for years, but they have only issued a warning a few months after the U.S. Food and Drug Administration (FDA) announced an investigation into the safety of the Da Vinci robot.
Intuitive also included a section titled “Precautions and Warnings for Usage of the EndoWrist Monopolar Curved Scissors”:
- Don’t apply energy when the tips of the Monopolar Scissors are not in contact with tissue (“air-firing”)
- Be aware of critical anatomy when firing the electrical scissors.
- Look at the surgical field, including areas below and behind the scissors, which may not be visible from the viewfinder.
- Only use EndoWrist instruments that have been validated.
- Consider the patient’s condition and any factors that could increase their risk of injury (radiation therapy, for example).
- Don’t exceed the maximum monopolar cautery settings, because this may result in electrical arcs and burns outside the surgical area.