December 6, 2013 — Intuitive Surgical has announced a Class II recall for the da Vinci robotic surgery system. The recall involves nearly 1,400 components used in the robotic arm. Intuitive warns that surgeons may feel friction or resistance. If the surgeon pushes through the resistance, the arm can momentarily stall and then suddenly catch up, resulting in imprecise surgical cuts.
According to the Class II recall notification, the U.S. Food and Drug Administration (FDA) believes there is a remote chance of serious complications, but the defect may cause “temporary or medically reversible” complications.
Out of approximately 55,000 procedures, the FDA has received 1 report of an imprecise cut and 2 cases of perceived resistance. The problem affects 1,368 Patient Side Manipulators (PSM), also commonly referred to as the “instrument arm,” which hold and drive the EndoWrist instruments. The daVinci S, Si, and Si-e Surgical Systems use the PSM component.
Intuitive started warning surgeons about the problem in November 2013, and they have reportedly inspected about 70% of the components. The Wall Street Journal reported that a spokeswoman for Intuitive said that “The number of arms requiring any adjustment is minimal.”