DaVinci Announces Recall
Written By: Paul Rheingold
Intuitive Surgical on May 8 made an "Urgent Medical Device Notification" relating to the hot shears on the da Vinci robot (also called monopolar curved scissors), due to the risk of stray electricity leaking to organs and tissue, causing thermal burns.(#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 the McCalla case and others, that there is a serious risk that the use of monopolar current in the da Vinci robot machines will cause burns t o tissue. Such burns may go undetected during surgery and manifest themselves only later when reoperation 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 legally both in showing what doctors should be alert to and may be doing wrong, 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.