May 13, 2013 — Intuitive Surgical, the manufacturer of the Da Vinci Surgical Robot, has issued an Urgent Medical Device Notification for the EndoWrist Instrument Monopolar Curved Scissors (a.k.a. “Hot Shears”) because small cracks in the insulation may allow electrical currents to burn patients during surgery. According to the notice, “These micro-cracks may not be visible to the user.”
While Intuitive claims they have only found one complaint of an injury caused by the Monopolar Curved Scissors in which micro-cracks were found, the FDA has received thousands reports of injuries, including many “unexplained” burns and electrocutions. Intuitive is also currently facing numerous lawsuits involving this injury.
On lawsuit, filed by plaintiff Elisa Rister and her husband on July 26, 2012 in the U.S. District Court for the Northern District of California, underwent a hysterectomy with the da Vinci Surgical Robot because she was told that she would heal faster, have a better outcome, and less pain. Instead, the robot damaged her ureter and caused long-term injuries.
According to the complaint:
“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.”
Although Intuitive has been receiving complaints about the Monopolar Curved Scissors for years, they have only now issued warnings about the instrument — just a few months after the U.S. Food and Drug Administration (FDA) announced an investigation into the safety of robot surgery.
In a section titled “Precautions and Warnings for Usage of the EndoWrist Monopolar Curved Scissors”, Intuitive warnings included:
- Do not apply energy when scissor tips are not in contact with tissue (“air-firing”).
- Be aware of critical anatomy in contact with the instrument during energy activation.
- Survey the surgical field … including areas “below” or “behind” the cannula and endoscope that are normally outside the field of view.
- Only use validated EndoWrist monopolar instruments.
- Consider patient conditions that could make them more susceptible to injury (such as radiation therapy).
- Do not exceed maximum monopolar cautery settings. “Exceeding the maximum cautery settings … may result in electrical arcs and alternate site thermal injuries.”