Recall of da Vinci Surgical System

Posted on January 22, 2014 · Posted in News

In December, the FDA announced a Class II recall of two components of the da Vinci surgical system, a robot designed to aid in surgery procedures by Intuitive Surgical Inc. (ISI) The popularity of these robots has risen drastically in the past two years, but has recently been under question for its safety and reliability. In the past year, more than 70 products liability claims have been filed in the federal court against the product’s manufacturer, along with dozens more in state courts. More claims are expected to be filed in the meantime.

So what is wrong with the robots, exactly? Due to abnormal friction, the arms of the instrument can get stuck, causing serious problems for surgeons and doctors during a procedure. In one instance, the robot arm made an imprecise incision during a urethral procedure, and in another, doctors had to remove the instrument from the table due to a malfunction.

Another Class II recall was announced after ISI recalled specific lots of da Vinci’s EndoWrist needle drives that are used for guiding surgical instruments. The recall was due to 82 reports of malfunctioning or detached needle drive jaw inserts, 27 cases involving the inserts falling off during a surgery procedure.

The Journal for Healthcare Quality wrote about many surgery complications involving these robots going unreported, and goes on to suggest the making of a standardized robotic device reporting system that would be used to evaluate the effectiveness and safety of the robots in use. Another small study revealed that 10 out of a reported 11 health care providers experienced problems with the robots, although it was noted that the sample in the survey was too small, considering just how many hospitals and practices are using the robots across the country.

Right now Intuitive Surgical Inc. is defending itself from its insurance company, although the damage may be done. The agency is calling for hospitals and doctors to be extensively trained with each type of robot, and should be credentialed for use to minimize the likelihood of malfunctioning and complication. One thing that is clear: a better study needs to be conducted to analyze the effectiveness and success of the robots in comparison to the risks associated with their use.

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