Lawsuit Filed After Blade Falls Off During Robotic Surgery with da Vinci

A Michigan woman has filed a product liability lawsuit against the makers of the da Vinci surgical system, after the robot’s surgical blades allegedly fell off in the middle of a robotic hysterectomy. 

Lawanda Salisbury, of Wayne, Michigan, filed a complaint (PDF) against Intuitive Surgical, Inc. on July 6, in the U.S. District Court for the Eastern District of Michigan.

According to allegations raised in the lawsuit, Salisbury was undergoing surgery in 2009, when a da Vinci robot failed mid-operation, turning what would have been a minimally invasive procedure into open abdominal surgery that left lasting scars and complications.

The da Vinci Surgical System is a complex, remote-controlled robot that has been heavily marketed and increasingly used in recent years for a number of surgical procedures to provide a less invasiv surgery, which reduces recovery time. The lawsuit alleges that Salisbury chose to have robotic surgery with a da Vinci machine for her total hysterectomy for just that reason.

During surgery, a blade on the robot’s monopolar scissors, known as the Hot Shears, broke off and became lost. Salisbury’s surgeon immediately halted the procedure once the broken scissors were noticed and became concerned that the broken blade was lost inside of Salisbury’s body. He commenced an open abdominal hysterectomy, while exploring her abdomen for the broken blade, which is only half a centimeter in length. The blade was eventually found in her body and removed.

Intuitive Surgical recommends the Hot Shears tool for hysterectomies, and claims that they should be good for about 30 uses. According to the lawsuit, Henry Ford Hospital, where Salisbury’s surgery was performed, only used the Hot Shears for 10 procedures as standard practice.

The lawsuit states that Salisbury was forced to undergo a more extensive and invasive procedure than she had consented to or anticipated, increasing her risk of death and injury, time in the hospital and recovery. It also left her with scarring she had undergone da Vinci surgery to avoid and she lost a significant amount of blood during the extended search for the missing broken blade.

The lawsuit charges Intuitive with manufacturing and designing a defective medical device, negligence, and negligent misrepresentation.

In recent months, a growing number of product liability lawsuits over robotic surgery with the da Vinci system have been filed nationwide on behalf of individuals who experienced internal injuries and other complications during their procedure.  The machine has been linked to reports of internal tears, burns and other problems. 

While some of the lawsuits allege that problems during da Vinci robotic surgery were caused by a lack of adequate training provided by the manufacturer, other complaints allege that the system features design defects, which cause injury to nearby organs, vessels or tissue when the monopolar energy used to cut, burn and cauterize tissue jumps or “arcs” outside of the surgical field.

Salisbury’s complaint is believed to be the first lawsuit filed involving problems caused by the blades falling off of the da Vinci robot during surgery

In May, a motion was filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate and centralize all federal lawsuits over da Vinci robotic surgery before one judge for coordinated handling during pretrial proceedings. There are currently only about a half-dozen lawsuits filed in U.S. District Courts throughout the United States, but as as da Vinci robot lawyers file additional cases that are currently being investigated, the litigation is expected to continue to grow.

Photo courtesy of http://en.wikipedia.org/wiki/User:Nimur / CC by 3.0