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A bay area patient has died in such surgery, but the FDA says there is no indication it's riskier than standard procedures.
By GRAHAM BRINK, Times Staff Writer
© St. Petersburg Times
published October 31, 2002
TAMPA -- The robot system used in the surgery that led to the death of an area high school teacher is part of a new wave of robotics changing the way many surgeries are conducted.
Advocates say the system is less invasive and leaves the patient with less pain, less bleeding and a faster recovery.
Plant High biology teacher Al Greenway, 53, died Oct. 13 at St. Joseph's Hospital, two days after a surgeon used the robotic da Vinci Surgical System to remove a cancerous kidney. During the surgery, two blood vessels, including the aorta, were cut accidentally.
Dr. Tod Fusia, the surgeon involved in the operation, said through his lawyer Wednesday that it was a tragic incident that he'll live with for the rest of his life. He did not want to comment further.
Hospital officials said an evaluation confirmed the robot had not malfunctioned. It is still in use in certain types of surgeries at the hospital.
"This system is a godsend," St. Joseph's president Issac Mallah said Tuesday.
The Food and Drug Administration approved the da Vinci in July 2000 for use in abdominal surgeries such as gallbladder removal and surgery for severe heartburn. Last year, the FDA okayed the da Vinci for certain surgeries involving the lungs, esophagus and the internal thoracic artery and for removal of the prostate.
The FDA cleared da Vinci to grasp, cut, dissect and suture tissue.
The robot has also shown promise for helping in heart surgeries, in which it allows the surgeon to make small incisions in the rib cage to access the surgical site instead of cracking open the patient's breastbone.
So far, California-based Intuitive Surgical Inc. has sold about 133 of the $1-million da Vinci machines throughout the world. More than 50 hospitals in the United States use the systems, including two in Miami, one in Ocala and Tampa's St. Joseph's Hospital, which began using its da Vinci about five months ago.
As of May, according to the FDA, there hadn't been any indications that robotic surgery was riskier than standard procedures. And there haven't been any patient injuries or deaths related to robotic system failures, the FDA said.
Lonnie Smith, president of Intuitive Surgical, said the company had not received notice of any serious injuries being caused by the da Vinci.
"The more surgeries that are approved, the more popular these systems will become," he said. "They are safe, reliable and a big plus for patients."
Robot systems have been used in Europe for about five years.
The robotics are an extension of traditional laparoscopic surgery in which a surgeon enters a patient's abdomen through several small incisions, not one large opening. A long tube with a miniature video camera at the tip is inserted into one of the incisions to allow the surgeon to look around.
With the help of long tubes, the surgeon slides rods into the incisions that have scalpels, scissors or other surgical tools at the end. The surgeon then uses handles to manipulate the tools to perform the operation.
The da Vinci systems take the tools out of the surgeon's hands, sort of.
The robot, responding to the surgeon's requests, moves the tissues and vessels out of the way and makes the cuts. The surgeon controls the system at a console about 10 feet from the operating table using two hand joysticks and foot pedals.
Another surgeon stands close to the patient to observe the site and move the camera, if needed. A 3-D screen helps magnify the surgical site so that tiny veins seem as thick as ballpoint pens.
Proponents of the system say the advantages are numerous.
The da Vinci system mimics the surgeon's hand movements, minus any tremors, no matter how slight. The system can scale back the speed of the scalpels and other surgical tools to as slow as one-tenth of the surgeon's movements, making intricate cuts easier to execute.
The robot can also operate in tiny spaces without causing the amount of damage to surrounding tissue that can come with hands-on surgery, they say. Surgeons boast of less fatigue, too.
But the system is not without detractors.
Some surgeons think they give up valuable tactile feedback when they don't have their hands on the patient. Also, the procedures with the da Vinci often take longer, which can place added risk on the patient.
The training isn't easy, and some surgeons don't get the hang of the system. An FDA report stated it takes up to 18 patients before surgeons feel comfortable and are able to perform the operations as quickly as with standard techniques.
St. Joseph's officials said Dr. Fusia, 44, had completed all the proper training and was highly skilled with the system. He had performed about 10 similar kidney removals and many prostate removals with the system.
Fusia's license is in good standing and he has no successful liability claims against him exceeding $5,000 in the past 10 years, according to state records.
-- Times news researcher John Martin contributed to this report. Graham Brink can be reached at (813) 226-3365 or firstname.lastname@example.org .