FDA Issues Two Medical Device Recalls for da Vinci Surgical Components

The U.S. Food and Drug Administration issued two more Class II da Vinci robot recalls amid reports that parts may slip off the robots during medical procedures.

The Class II designation affects more than 110,000 components of the da Vinci Surgical System.  Intuitive Surgical Inc. recalled its Large Needle Driver and Mega Needle Driver EndoWrist instruments in November; the FDA Class II designation followed a month later.

The reason behind the da Vinci surgical robot recall

A small metal piece, known as a jaw insert, may fall off the robots, according to reports. Intuitive Surgical claims that, though there is a very small chance that a detachment will occur, if it did happen, most surgeons would notice that a piece fell off during surgery. Also, a detachment would be noticed immediately if medical professionals looked at the robot, according to Intuitive Surgical.

The recalls are limited to the da Vinci instruments that were manufactured before October 2011. Any made after that date are not impacted, according to the company.

How the da Vinci surgical robot works

The da Vinci Surgical System is a remote control robot that allows doctors to perform surgery while sitting at a console. The station provides a virtual display of a patient’s internal organs. Surgeons use their hands and feet to control the robot’s four arms. Surgical robots are used to perform a variety of surgeries, including urologic and gynecologic procedures, in hospitals across the nation.

Other da Vinci robot problems

The da Vinci robot recall that was announced just weeks prior to these subject recalls impacted 1,400 arms that had the potential to stall during procedures.

Intuitive Surgical warned medical professionals in May that its da Vinci robot cauterizing scissors have parts that may crack and cause an electrosurgical energy leak, which could result in burns or thermal injuries to patients’ internal organs.

Two months later, a Class II da Vinci robot recall was issued because approximately 30 of the surgical systems were distributed without being properly tested. After the recall, the robots were tested, showing no problems. This triggered the FDA to send a warning letter to Intuitive Surgical, chastising the company for failing to sufficiently report problems with their surgical robots.

In addition, the surgical robots recently been linked to reports of patients suffering internal injuries, burns and tears following robotic surgery. The FDA has received a 50 percent increase in reports of da Vinci robot surgery complications during the last year. Reports includes cases of serious injuries such as perforated bowels, and even patient death.

According to published reports, at least 50 da Vinci surgery lawsuits have been filed by individuals against Intuitive Surgical, claiming they suffered serious injuries from the da Vinci Surgical System.

Despite the reported problems, some members of the medical community have said robot-assisted surgery is promising for the future. However, they have some concerns. The use of surgical robots make it difficult for medical professionals to compare the difference between physician and device mistakes. Some professionals also have said the benefits from robot-assisted procedures are inconsistent.

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