Intuitive Trainer Denies Robot Surgery Training Was Watered Down
Intuitive Surgical Inc. didn’t cut corners in a training program for surgeons to use its robots and met all the objectives submitted to federal regulators, a witness testified in a wrongful death case against the company.
Kate Lederer, a training specialist with the Sunnyvale, California-based company, said she continued teaching “in explicit detail” all the 23 skills listed on a checklist for surgeons contained in a document submitted to the U.S. Food and Drug Administration when the company sought clearance in 2000 for its da Vinci robotic surgical system.
Lederer rebuked the accusation by lawyers suing the company that the program had been “watered down” so that surgeons could be more quickly certified.
The trial in state court in Port Orchard, Washington, now in its fourth week, is the first of at least 26 lawsuits against Intuitive alleging injuries tied to the da Vinci system. The robots were used in more than 300,000 U.S. operations last year.
The case on trial was brought by the widow of Fred Taylor, who claims the training Intuitive provided for the robotic surgery was compromised by aggressive marketing, leading to errors in the removal of Taylor’s prostate gland in 2008 that eventually caused his death four years later.
The urologist who operated on Taylor, Scott Bildsten, had performed 100 successful prostatectomies using traditional methods; Taylor was Bildsten’s first patient using the da Vinci unassisted.
During her testimony, Lederer explained why a three-day learning session at Intuitive, which was part of the FDA clearance, was reduced to one day, or two days, depending on what participants wanted. She said that when the program was designed in 1999, hospitals and staff didn’t have access to da Vinci machines.
By 2008, the robots had become prevalent in large urban medical centers, making it possible for the company to use these machines for introductory instruction for surgeons, Lederer said. These sessions replaced one day of training previously held at Intuitive labs, she said.
Lederer said the training had actually improved by the time Bildsten took a one-day instructional course at company headquarters.
During cross-examination, plaintiff’s attorney Richard Friedman pressed Lederer on whether the company went beyond teaching equipment skills into clinical training.
She said she only taught doctors how to use the robots, not how to operate on patients.
“It’s expected surgeons understand surgical techniques,” she said, “regardless of da Vinci or non da Vinci.”
In robotic surgery, a doctor sits at console several feet from the patient and peers into a high-definition display. Foot pedals and hand controls maneuver mechanical arms equipped with surgical tools, guided by a 3D camera that shows the work as it is done inside a patient.
The case is Estate of Fred E. Taylor v. Intuitive Surgical Inc. (ISRG), 09-2-03136-5, Superior Court, State of Washington, Kitsap County (Port Orchard).
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