da Vinci Robotic Surgery

da Vinci Recall Notification & Surgical Usage Precautions

May 8, 2013: Intuitive Surgical made an “Urgent Medical Device Notification” relating to the hot shears (also called monopolar curved scissors) on the da Vinci robot due to the risk of stray electricity leaking to organs and tissue, causing thermal burns. (Notification #2955842-05-07-2013-005)

The significance of this recall is much broader than just the alleged basis for the notification-micro-cracks found in a few arms. The recall notice, when read carefully, demonstrates what we have claimed all along in our New York State groundbreaking McCalla case and others: That there is a serious risk that the use of monopolar current in the da Vinci robot machines will cause tissue burns. Such burns may go undetected during surgery and manifest themselves only later when corrective surgery is needed and permanent damage or death may have occurred.

In fact, the recall notice contains an attachment which outlines the risks of burns. This is useful for legal claims in that it both shows what doctors should be aware of, and what has been concealed from doctors by Intuitive up to now. These points are:

• Don’t do “air firing” -allowing a gap between the scissors and the tissue, as this allows the current to arc to other tissue
• Watch out for burns below or behind the operative field the surgeon can see (by inspecting after doing the surgery)
• Be careful using in patients who are more susceptible to electrical burn, such as ones who have had radiotherapy.
• Do not exceed a certain maximum in energy setting on the monopolar hot shears as this will lead to thermal burns.

Injuries Resulting from robotic surgery

Common types of injuries due reported, particularly to the FDA are: burns, tears of the intestines, punctured blood vessels or ureters, severe injury to the bowels, vaginal cuff dehiscence, excessive bleeding, and death. Injuries can be exacerbated because of delayed diagnosis.

Cutting and cauterizing the internal organs is accomplished by electrical current which is passed through robotic instruments. Due to the use of monopolar energy (as opposed to bipolar energy), increased the risk of burns occurs. This results from current which jumps from the instrument to the body part.

The surgical device responsible for these injuries is known as the “da Vinci,” manufactured by Intuitive Surgery, Inc., a California company. While literature touts a good safety record, there are instances where the robot has not responded to doctors’ commands. Another issue has been inadequate training on the machine. Surgeons may fail to notice that the machine caused an insidious complication.

davinci & product liability

Product liability suits against Intuitive Surgical may allege: improper design of monopolar circuits and failure of the insulating barriers. Failing to train surgeons how to use the da Vinci properly is also considered in these injury claims.

Our New York personal injury lawyers have successfully handled numerous faulty medical device lawsuits and have won many verdicts and settlements for people who have suffered. We offer our clients personal, attentive and individualized service from a skilled team of attorneys.