Da Vinci Robot Recall Affects Over 1,300 Devices

A da Vinci robot recall was announced on Tuesday by the U.S. Food and Drug Administration, after the manufacturer, Intuitive Surgical,  issued a “voluntary product correction” for da Vinci Patient Side Manipulators (PSMs). Intuitive Surgical warned the mechanical arms on some of its da Vinci robots could stall during robotic surgery.

The FDA states this is a Class II medical device recall, which means the agency believes the problem could typically result in temporary or medically reversible health issues, but could also pose a risk of serious injury in rare cases.

Intuitive Surgical inspecting and repairing robots

Intuitive Surgical warned hospitals and other medical providers that the robot’s instrument arms need to be replaced. It announced it is inspecting affected robots and repairing or replacing the arms when necessary. The company claims nearly 70% of the inspections had been completed and the majority of the arms did not need adjustment. The recall affects 1,386 Patient Side Manipulators on da Vinci S, Si and Si-e Surgical Systems.

There have been a number of da Vinci robot problems, including several incidents involving 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. These accidents and other adverse event reports have prompted further investigation by the FDA.

The da Vinci Surgical System is a remote control robot with four arms that are controlled by a surgeon through the use of hand and foot controls. The surgeon sits at a console that provides a virtual reality representation of the patient’s internal organs while the surgeon controls the arms. According to at least three complaints, friction within the PSM arms may interrupt the arm movement, causing them to stall or become stuck. “This can be felt by the surgeon as resistance in the movement of the master,” the FDA reports. “In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.”

Other recent Da Vinci robot problems

Other da Vinci robot problems for Intuitive Surgical have emerged in recent months.

• In July, the FDA reported that a Class 2 da Vinci robot recall was issued by the manufacturer after it was discovered that about 30 of the surgical systems were not properly tested before being distributed. Although they were subsequently tested in the field without any problems being discovered, concerns were raised about whether the factory testing was in compliance with UL standards.
• In March, the NY times revealed critics’ concerns regarding the quality of surgeon training.
• According to Medscape.com, Intuitive Surgical issued a warning to health care providers in May of 2013 about problems with the da Vinci robot cauterizing scissors, stating the components may develop micro-cracks that allow electrosurgical energy to cause thermal injury or burns to internal organs.

The limited scope of the recent recall means that da Vinci robotic surgery remains a widespread practice in hospitals all over the country.