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Da Vinci Lawsuit Alleges Death Caused by Errors, Insufficient Training
March 29, 2013
Any parent who has ever watched their child play at a video game could not have dreamed that one day that child could grow up to become a surgeon and perform operations the same way. Not only has it come to pass, by way of Intuitive Surgical Inc.’s da Vinci robotic surgical system, but patients have suffered da Vinci Robot injuries. Others have died allegedly due to improper training on the high-tech system.
A da Vinci lawsuit claiming the system led to the death of a patient is set to go to trial April 15, according to Bloomberg News (3/26/13). In the same article, it was reported that defendant Intuitive’s attempt to have the lawsuit thrown out was denied.
The robot lawsuit was filed by the family of Fred Taylor, the deceased plaintiff who underwent robotic surgery for a prostate procedure in 2008. The family maintains the surgeon who performed the procedure using the controversial da Vinci robotic system was insufficiently trained, and elected to perform the procedure without supervision too soon.
Fred Taylor, according to court documents cited in the Bloomberg report, suffered a one-inch tear in his rectum as a result of the robotic surgery. The patient also suffered kidney failure, brain damage and permanent incontinence, and later died of heart failure due, his family alleges, to da Vinci robot injury.
The da Vinci Robot lawsuit contends it was the first time the doctor who performed the surgery had ever used the system on a patient without supervision, after having performed only two other prior surgical procedures with supervision.
The lawsuit contends among the errors made by the surgeon of record was his decision to use the robotic system in the first place. The lawsuit also contends that Intuitive failed in its responsibility to adequately train surgeons and then recommend the undertaking of unmonitored procedures too quickly.....read more
CNBC Investigation Uncovers New Information about Da Vinci Robotic Surgery; San Francisco Personal Injury Lawyer Jeff Nadrich Responds
March 29, 213
CNBC Investigations, Inc. has launched a thorough investigation into the safety and effectiveness of the da Vinci Surgical System, manufactured by Intuitive Surgical, Inc. A summary of that investigation was published on March 19th at CNBC.com. The investigation has uncovered new information about reported injuries and deaths stemming from surgeries performed with the da Vinci device.
The da Vinci robotic device is used to conduct complex surgeries in a minimally invasive manner. Common procedures include hysterectomies and prostate removals. A trained physician controls the device remotely while observing a 3D monitor. According to CNBC, the manufacturer collected more than $2 billion in revenue last year alone.
Among other things, CNBC reported that “a high-pressure sales culture driven by quarterly ‘quotas’ on surgical procedures has led sales people to lean on surgeons to do more robotic surgeries,” and that there has been “a sharp rise in lawsuits and complaints about injuries, complications and even deaths following da Vinci procedures.”
San Francisco personal injury lawyer Jeff Nadrich has been following the news and latest research, and believes that many da Vinci patients may be entitled to compensation.....read more
Robotic surgery tied to temporary nerve injuries
March 29, 2013
(Reuters Health) - One in 15 people undergoing robot-assisted prostate, kidney or bladder surgery develops a nerve injury related to pressure from positioning on the operating table, a new study suggests.
Patients on the table getting those types of robotic surgery need to be tilted steeply - with their head by the floor and their feet in the air - to give the surgeon better traction, researchers explained.
"When somebody is in that position, there's a chance they could slide down - it's like a big ramp," said lead author Dr. Tracey Krupski, from the University of Virginia School of Medicine in Charlottesville.
"When you slide, you then could be pulling, or having the drag on some of the nerves. It's like a constant pulling on the muscle."
Earlier this month, the Food and Drug Administration announced it would be taking a closer look into safety reports regarding da Vinci surgical robots, made by Intuitive Surgical. The robots cost about $1.5 million each.
For the new study, Krupski and her colleagues reviewed records from 334 robot-assisted urology procedures done at their institution in 2010 and 2011. Those included prostate, kidney, adrenal gland and bladder surgeries.
A total of 22 patients - between six and seven percent - woke up with a positioning injury after their procedure, including weakness, numbness or immobility in the hands or feet. More than half of the injuries resolved within a month, but five lasted more than six months, the study team reported in The Journal of Urology.....read more
Published on Mar 28, 2013
Performing surgery on a pregnant patient is a delicate matter. Risks to both mother and baby must be carefully weighed in every decision a surgeon makes. Recently, at the University of Texas Medical Branch at Galveston, a surgeon performed a groundbreaking robotic laparoscopic procedure on a 35-year-old pregnant patient whose cervix was too short to sustain a pregnancy.
Dr. Sami Kilic, chief of minimally invasive gynecology and research at UTMB, is the first surgeon in the world reported to have used robotically assisted, ultrasound-guided laparoscopic surgery to successfully tighten a pregnant patient's incompetent cervix. The procedure is explained in a new paper now online in the Journal of Minimally Invasive Gynecology. When performed traditionally, abdominal cerclage surgery requires a large incision and a long period of recovery. Kilic's new procedure left the patient with only three tiny abdominal scars.....read more
Manufacturer faces lawsuits after surgery robot arm breaks off in patient’s rectum
March 27, 2013
Surgeons in Aalst, Belgium were startled when part of the robot arm of a da Vinci surgery robot broke off inside a patient who was undergoing prostate surgery in 2007. According to New Scientist magazine, that incident and others have sparked a rash of lawsuits against Intuitive Surgical, Inc., the company that makes the surgical robots. This news comes after a recent study by Columbia University researchers found that robotic surgery has no real advantages over live surgeons with proper instruments and training.
Other alleged complications from the da Vinci machines include punctures to the liver and spleen during heart surgery, rectal damage during prostate surgery, unintended burns from the device’s cauterizing tools and vaginal hernias following hysterectomies.
In the Belgian case, surgeons found themselves unable to remove the damaged robot part. The fracture of the robotic arm bent it so badly that it could not be pulled back out through the original keyhole incision. They ended up having to enlarge the wound to retrieve the damaged part.....read more
Intuitive Surgical Inc. via Bloomberg
Robot Surgery Isn’t First Choice for Uterus Removals
March 15, 2013
Robotic surgery for hysterectomies doesn’t improve outcomes and shouldn’t be the first choice for most women, a doctors’ group said, sending Intuitive Surgical Inc. (ISRG) to its lowest value in almost 14 months.
The American Congress of Obstetricians and Gynecologists, which represents 56,000 U.S. physicians, said expertise with Intuitive’s da Vinci robot system is limited and surgeons learning the new technology may have higher rates of complications. Intuitive, based Sunnyvale, California, sells the only robotic system approved in the U.S. for soft tissue procedures that include gynecological surgery.
“There is no good data proving that robotic hysterectomy is even as good as -- let alone better -- than existing, and far less costly, minimally invasive alternatives,” James T. Breeden, the organization’s president, said in a statement posted yesterday on the group’s website.
Angela Wonson, a spokeswoman for Intuitive, defended the product, saying in an e-mail that “evidence supports that robotic surgery has dramatically decreased the number of open hysterectomies in the U.S.”
The U.S. Food and Drug Administration is surveying surgeons about the safety of the machines, their training and how the robots are used, Bloomberg News reported last month. Data published in February found that use of the Intuitive robots, priced at $1.5 million each, drives up surgical costs by as much as $2,189 per procedure without reducing complications compared with standard less-invasive procedures.
Intuitive fell 6.2 percent to $459.44 in New York, its lowest closing price since Jan. 30, 2012. The company has declined 20 percent since Feb. 27, the day before the FDA survey became public.....read more
Statement on Robotic Surgery by ACOG President James T. Breeden, MD
The American College of Obstetricians and Gynecologists
Washington, DC -- March 14, 2013
Many women today are hearing about the claimed advantages of robotic surgery for hysterectomy, thanks to widespread marketing and advertising. Robotic surgery is not the only or the best minimally invasive approach for hysterectomy. Nor is it the most cost-efficient. It is important to separate the marketing hype from the reality when considering the best surgical approach for hysterectomies.
The outcome of any surgery is directly associated with the surgeon’s skill. Highly skilled surgeons attain expertise through years of training and experience. Studies show there is a learning curve with new surgical technologies, during which there is an increased complication rate. Expertise with robotic hysterectomy is limited and varies widely among both hospitals and surgeons. While there may be some advantages to the use of robotics in complex hysterectomies, especially for cancer operations that require extensive surgery and removal of lymph nodes, studies have shown that adding this expensive technology for routine surgical care does not improve patient outcomes. Consequently, there is no good data proving that robotic hysterectomy is even as good as—let alone better—than existing, and far less costly, minimally invasive alternatives.
Vaginal hysterectomy, performed through a small opening at the top of the vagina without any abdominal incisions, is the least invasive and least expensive option. Based on its well-documented advantages and low complication rates, this is the procedure of choice whenever technically feasible. When this approach is not possible, laparoscopic hysterectomy is the second least invasive and costly option for patients.
Robotic hysterectomy generally provides women with a shorter hospitalization, less discomfort, and a faster return to full recovery compared with the traditional total abdominal hysterectomy (TAH) which requires a large incision. However, both vaginal and laparoscopic approaches also require fewer days of hospitalization and a far shorter recovery than TAH. These two established methods also have proven track records for outstanding patient outcomes and cost efficiencies.
At a time when there is a demand for more fiscal responsibility and transparency in health care, the use of expensive medical technology should be questioned when less-costly alternatives provide equal or better patient outcomes. Hysterectomy is one of the most common major surgeries in the US and costs our health care system more than $5 billion a year......read more
Buffalo-Based Team Develops, Tests First Simulation-Based Robotic Surgery Training Curriculum
March 12, 2013
Study results indicate Fundamental Skills of Robotic Surgery appears to be effective way to train surgeons.
Researchers from Roswell Park Cancer Institute (RPCI) and four collaborating institutions have evaluated the effectiveness of a novel curriculum to safely train surgeons on the da Vinci Surgical System, which is used to perform robot-assisted surgeries. Results, published in Urology, showed that participants trained in the curriculum executed key skills with greater precision than those who did not receive training.
The Fundamental Skills of Robotic Surgery (FSRS) training curriculum, jointly developed by the study authors, uses the Robotic Surgical Simulator (RoSS) to train surgeons in four basic areas required in robot-assisted surgeries: orientation, motor skills, basic surgical skills and intermediate surgical skills. Launched in 2010, RoSS, one of the first robotic surgical simulators to accurately simulate the da Vinci system, was developed by Khurshid A. Guru, MD, director of robotic surgery at RPCI, and Thenkurussi Kesavadas, PhD, director of the Virtual Reality Lab and a professor of mechanical and aerospace engineering at the University at Buffalo (UB).....read more
New lawsuits, deaths bringing more scrutiny for robot surgery
March 7, 2013
After Michelle Zarick complained of excessive vaginal bleeding, her doctor found growths in her uterus that needed to be removed. One option: robot surgery, described by her gynecologist as “the latest, greatest” technique available.
With nimble robotic instruments doing the delicate work usually performed by doctors hands-on, there would be less pain and bleeding, she was told.
“In my mind, there was no alternative but to use this fabulous technology,” she recalls thinking.
Five weeks later, she wished she hadn’t. That’s when Zarick felt something pop while she was in the bathroom, looked down and saw her intestine protruding from her vagina. Now, four years later, the 41-year-old Zarick has a hip-to-hip scar from corrective surgery, constipation from damaged rectal muscles and a diminished sex life, she said in an interview.
"It didn’t help me one bit, the robot,” said Zarick, who lives in Lincoln, California and filed suit in December against Intuitive in regard to her hysterectomy. “It forever changed my life for the worse.”
Robot systems made by Intuitive Surgical Inc. (ISRG) are linked to at least 70 deaths in informal incident reports sent to U.S. regulators since 2009, according to a review by Bloomberg News. Now, lawsuits like Zarick’s, one of at least 10 filed in the last 14 months, are adding new details about dangerous complications involving the da Vinci robots made by Intuitive.....read more
Robotic Surgery Errors: Is Intuitive Surgical Really to Blame?
March 5, 2013
Intuitive Surgical (NASDAQ: ISRG ) has become one of the most debated stories in the health-care industry in recent weeks. In addition to negative reports from the investment and medical communities in recent months, the company behind the da Vinci robotic surgery platform has fallen prey to Bloomberg's recent discovery of an FDA "inquiry" into topics including procedure safety and surgeon training.
However, as Brenton Flynn highlights in the video, one thing that hasn't received as much attention as it deserves is the human element of surgery. User error will always be a variable at work, and Brenton thinks it's a big feather in Intuitive's cap.....read more
Florida Hospital Performs First Pediatric Robotic Surgery
March 4, 2013
ORLANDO, Fla. A team of leaders from Florida Hospital recently visited Colombia where they performed the first pediatric robotic surgery in Latin America on a two-year-old boy. The first-of-its-kind surgery was done at Clinica Marly in Bogata, Colombia.
Dr. Pablo Gomez III, Medical Director of the Pediatric Urology Robotic Program at Florida Hospital for Children and native of Bogota, Colombia, performed the surgery. Dr. Gomez, a third generation urologist from Bogota who attended Medical School at Universidad del Roasario and completed a Pediatric Urology Fellowship at Boston Children's Hospital with Harvard Medical School, performed the procedure on a child with a congenital anomaly. Prior to the surgery, Dr. Gomez was also invited to give a lecture on "Robotic Surgery in the Pediatric Patient” to key physicians and health care leaders looking to bring robotic surgery to the region....read more
Surgeons practice using the "da Vinci" robotic surgical system, which is used to repair torn heart valves without having to open an incision in the patient's chest. The system, originally designed for use in battlefield conditions during a chemical or biological attacks, is used by doctors at Manhattan's New York-Presbyterian Hospital for heart operations.
The safety of robots made by Intuitive Surgical Inc. (ISRG) is being probed by U.S. regulators, raising questions about the prospects of one of the hottest technologies in health care.
The Food and Drug Administration asked surgeons at key hospitals to list the complications they may have seen with the machines, which cost about $1.5 million each and were used last year in almost 500,000 procedures. The doctors were also surveyed on which surgeries the robots might be most and least suited for, and asked to discuss their training, according to copies of the survey obtained by Bloomberg News.
The answers may sway debate on whether robotic surgeries promoted as being less invasive are worth the extra cost. The findings may also determine the outlook for Intuitive. The da Vinci surgical system and related products generated most of the Sunnyvale, California-based company’s $2.2 billion revenue in 2012, and helped boost market value 70 percent over three years to about $23 billion, according to data compiled by Bloomberg.....continue reading
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