FDA Approves New da Vinci Robot, but Intuitive Still Faces Lawsuits

The U.S. Food and Drug Administration has given clearance to Intuitive Surgical Inc.’s updated model of its da Vinci surgical robot. The company reportedly met all the criteria of the FDA warning letter issued last July. This warning came on the heels of a massive recall of the da Vinci surgical systems a month prior.

The FDA had taken issue with how Intuitive handled problems that occurred during da Vinci robotic surgeries as well as the design of the equipment. The FDA mandated a large scale recall of all da Vinci surgical robots after several physicians and hospitals reported cases of the malfunctions during the robot surgeries. Defective wiring and insufficient insulation of the wiring in the da Vinci surgical system resulted in some patients getting burned during laparoscopic surgery.

While the new da Vinci robotic surgery units are believed to be safer, Intuitive Surgical is still dealing with da Vinci robot surgery class action lawsuits over alleged da Vinci robot surgery complications.

History of the da Vinci Robot

Intuitive Surgical Inc. created the da Vinci Surgical Robot in the 1990s, based on United States military robotic technology. The da Vinci Robotic Surgical System has a three or four-armed robot connected to a remote console, where the surgeon then uses foot-pedals, hand controls, and a three-dimensional display to perform the delicate, and invasive operations.

Intuitive Surgical Inc. marketed the da Vinci robot as a safe surgery tool for use in the following procedures:

• thoracoscopic surgery
• laparoscopic radical prostatectomy
• thoracoscopically-assisted cardiotomy procedures
• mitral valve repair surgery
• totally endoscopic atrial septal defect
• gynecological laparascopic procedures

However, Intuitive Surgical Inc. allegedly overstated the effectiveness and safety of its surgical systems, according to Intuitive Surgical class action lawsuits. Additionally, Intuitive Surgical is accused of failing to inform the government, hospitals, doctors, and patients of the dangerous, and often life-threatening defects with the da Vinci robot.

The major defect in the da Vinci Surgical System lies in the faulty design of the electronics and insulation of the robot arms. Similar surgical robots use safer bipolar or ultrasonic currents. However, the da Vinci robot used monopolar currents and monopolar scissors to cut and cauterize tissues. The lack of proper insulation of the electronics wires and currents allowed excessive electrical currents to pass through a patient’s tissue. This can cause dangerous tearing in surrounding tissues and organs during the surgical procedures.

Join a Free da Vinci Robot Class Action Lawsuit Investigation

If you or a loved one were injured by da Vinci robotic surgery complications, you may have a legal claim. See if you qualify to pursue compensation and join a free da Vinci robot class action lawsuit investigation by submitting your information for a free case evaluation:

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