Intuitive Gets Class II Recall Label For Components Of Its Robotic Surgical System

By Sara Jerome,
@sarmje

The FDA announced that certain elements of the da Vinci line of surgical systems are subject to a Class II recall.

The system’s manufacturer, Intuitive Surgical, sent customers a recall notice last month, according to the agency.

“Reports of friction within certain instrument arms can interrupt smooth instrument motion,” the FDA’s announcement stated. “This can be felt by the surgeon as resistance in the movement of the master. In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.”

The FDA has named it a Class II recall, meaning “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote,” according to the agency. 

But Barron’s reported that the classification is “a bit misleading.”

“The instruments aren’t actually being recalled, but the agency uses the label to identify products that it thinks could cause ‘temporary or medically reversible’ health problems,” the analysis said. Intuitive Surgical has asked customers to inform their employees of the need to schedule machine inspections. 

Intuitive Surgical spokeswoman Angela Wonson commented in the Wall Street Journal: “Nearly 70% of these inspections are complete and the number of arms requiring any adjustment is minimal.”

There had already been reports of problems with the product, according to the Daily Mail, “including several disturbing incidents including a robotic hand that wouldn’t let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table.”

Intuitive shares have dropped in recent months. “Intuitive’s sales and share price have taken a hit this year,” Bloomberg reported. In October, the company reported “a decline in third-quarter earnings as a result of lower revenue.” This year, the company has lost nearly a quarter of its value.

“Since 2008 the FDA has issued five pages of recalls against the company,” according to The Street.

Med Device Online previously reported that the FDA released the results of an investigation into the da Vinci system in the wake of increased product litigation.

Image credit: Intuitive Surgical Systems