December 6, 2013 — Intuitive Surgical has issued a recall of about 1,400 components used in the da Vinci robotic surgery system. The problem is that friction within the robotic arm can interrupt the instrument’s motion. The robotic arms can momentarily stall during procedures and potentially cause imprecise surgical cuts.
The U.S. Food and Drug Administration (FDA) issued a Class II recall, meaning they believe the problem can cause “temporary or medically reversible” complications, with a remote possibility of serious problems.
Intuitive issued a Voluntary Product Correction that affects 1,386 Patient Side Manipulators (PSM) on da Vinci S, Si, and Si-e Surgical Systems. The PSM is commonly referred to as the “instrument arm,” which holds and drives the EndoWrist instruments.
Intuitive began warning surgeons about the problem in November. The company warned that surgeons may feel resistance. If they continue to push, the device may stall and then suddenly catch up, resulting in an imprecise cut.
The da Vinci robot recall was announced in response to 1 report of imprecise cuts and 2 cases of perceived resistance out of about 55,000 procedures. Intuitive has inspected about 70% of affected robots. According to a spokeswoman who spoke with the Wall Street Journal, “The number of arms requiring any adjustment is minimal.”