Patient severely injured in 2008 da Vinci prostatectomy in Washington state

What happened

On September 9, 2008, a surgeon at Harrison Medical Center in Washington state performed a prostatectomy using the hospital’s da Vinci Surgical System. As described in the Washington Supreme Court’s 2017 opinion, the surgeon had completed two such procedures under a proctor, and this was his first without one.

The court’s account says the patient weighed about 280 pounds, with a body mass index of 39, and had three earlier lower abdominal surgeries, whereas the manufacturer’s guidance advised a body mass index under 30 and advised against patients with prior lower abdominal surgery. Because of the patient’s weight, the surgeon did not use the steep head-down position the manufacturer recommended.

During the operation the patient’s rectal wall was lacerated. The surgeon abandoned the robotic approach and converted to open surgery, and another surgeon repaired the tear. Afterward the patient suffered respiratory failure requiring ventilation, kidney failure, infection, incontinence and neuromuscular damage, and needed a colostomy bag and help walking. He died about four years later; a doctor testified at trial that the complications hastened his death.

The system involved

The da Vinci Surgical System, made by Intuitive Surgical, is a set of robotic arms holding surgical instruments and a camera, all directed by a surgeon seated at a console. It carries out the surgeon’s hand movements rather than operating autonomously.

The hospital had purchased the system. The claim against Intuitive did not turn on a mechanical failure; it focused on what the company told the surgeon and the hospital about the risks of using the device.

Investigation and response

The patient sued the surgeon, the surgeon’s practice and the hospital, and later added Intuitive Surgical; after his death in 2012 his estate continued the case. The Associated Press reported that the claims against the surgeon and hospital were settled for undisclosed amounts. The product-liability claim against Intuitive went to trial in Kitsap County in 2013, and the jury found that the company was not negligent in warning or instructing the surgeon. The Court of Appeals affirmed in 2015.

On February 9, 2017, the Washington Supreme Court vacated the verdict by a 6-3 vote and sent the case back for a new trial. It held that under the state’s product liability law a manufacturer must warn the hospital that purchases a device, not only the physician who uses it, and that the jury should have been told so.

Intuitive said in a statement that the ruling did not account for trial evidence that it had delivered the hospital’s system with a user manual containing warnings and precautions, as it normally does.

What is not established

The outcome of the case after the 2017 remand was not found in the sources reviewed. The Supreme Court’s opinion does not name the city where the hospital is located, so the city is left blank here; the case was tried before a Kitsap County jury. Whether better warnings to the hospital would have changed the outcome was never decided by a jury.