What Is The da Vinci Robot And Robotic-Assisted Surgery?The da Vinci surgical robot, named after Leonardo da Vinci, has been marketed as a breakthrough in making surgery more efficient and less invasive. The da Vinci robot consists of a sophisticated 3D viewer camera and four remote control arms, which are supposed to enable surgeons to do operations such as a hysterectomy or a prostatectomy through smaller incisions but with better visibility and precision. Although da Vinci robotic surgery can be seen as a revolutionary innovation in health care -- and while the idea of this innovative breakthrough is certainly exciting, it comes at a cost -- not only money wise (up to $2 million per unit) but also, and more importantly, in terms of patient health and safety. Unfortunately, some individuals who have had operations performed through the da Vinci robot report that their doctors experienced unexpected problems during the robotic-assisted surgery. Other patients suffered post-operative complications associated with their da Vinci surgical procedure. Tragically, there are reports of patients who have died after having had da Vinci robot-assisted surgery. Damage Control: Dangers of da Vinci Surgery Robot
The da Vinci robot is currently used in about 1000 hospitals across America as well as hundreds of medical offices across the country, and robotic surgery has been touted by those health care facilities as a symbol of medical progress. In fact, however, some surgeons have questioned the way the da Vinci robot has been marketed. On the da Vinci surgery website it is marketed as:
But representatives of Intuitive Surgical, the designers and manufacturers of the da Vinci robot, have also marketed their surgical robot as a way for hospitals as well as medical offices to gain market share and, in turn, to increase revenue.
The da Vinci Robot According to an article in The Wall Street Journal (WSJ), "Surgical Robot Examined in Injuries", from May 4, 2010, a surgery performed on an elderly man with a stomach condition in June 2007 at Douglass-Wentworth Hospital in Dover, NH went terribly wrong when a doctor operated on the man for several hours with the da Vinci robot, but gave up and switched to a traditional, open surgery. The patient tragically died after his esophagus was perforated. Another example of an unfortunate incidence which occurred with robot-assisted surgery taken from that same May 2010 WSJ news article was a routine hysterectomy gynecological surgery performed on a woman on March 3, 2009 in which during da Vinci robot-assisted surgery the gynecologist accidentally cut both of the patient's ureters with the robot. Free Case EvaluationConfidential. No Obligation. You can use the online Case Evaluation form or you can: (1) Call attorney Tom Lamb at 800-426-9535 for a free consultation about your possible da Vinci robot products liability defect case or robotic surgery medical negligence lawsuit; or, (2) send him an email -- [email protected] -- with your description of the da Vinci surgical procedure that caused you a surgery-related injury or the death of a patient during or soon after the da Vinci surgery.
Intuitive Surgical, the embattled manufacturer of the da Vinci robotic surgical system, warned customers last week that certain versions of its cautery scissors may develop microcracks that could leak electrical energy and inadvertently burn tissue. The instrument in question, EndoWrist Hot Shears Monopolar Curved Scissors, is used to cut and coagulate tissue in a wide variety of procedures, including hysterectomy, prostatectomy, and gastric bypass. The scissors and other EndoWrist instruments are made exclusively for use with the da Vinci Surgical System.... Intuitive Surgical Flags ‘Potential Issue’ With Robot Intuitive Surgical, maker of the da Vinci surgical robot, has issued an "urgent medical device notification" alerting hospitals that it has "identified a potential issue" with one of the robot's instruments that can cause internal burns. To Read the full urgent notification, click here. (PDF document) Some of the [Adverse Event Reports (AERs)] on file with the FDA pertain to equipment malfunctions that resulted in no harm to patients during operations that ranged from hysterectomies to coronary artery bypass graft surgery. Other reports describe injuries and deaths, although they are not necessarily blamed on an equipment problem. In some cases, surgeons who operated robotic arms and the various tools attached to them punctured bladders, severed nerves and blood vessels, and otherwise appeared responsible for the mishaps. In other cases, the da Vinci surgical robot seemed to have a life of its own, at times inexplicably cauterizing a fallopian tube, damaging heart tissue, or refusing to let go of a patient's tissue with its grasper. "We had to do a total system shutdown to get the grasper to open its jaws," stated one report, noting that the patient was not injured.
Lately a key study and reports of problems have raised questions about robotic surgery’s safety and cost-effectiveness, leading to a review of the Da Vinci system by the Food and Drug Administration and causing some experts to wonder whether the benefits of undergoing robot-assisted surgery may have been overstated. Most robotic procedures take place without a hitch, but there are a growing number of complaints and lawsuits that allege complications and even deaths from the da Vinci surgery. Intuitive’s First Robot-Surgery Trial to Probe Training Intuitive Surgical Inc., a maker of surgical robots used in more than 300,000 U.S. operations last year, faces its first trial over claims it marketed the devices to doctors without providing adequate training. A state court jury in Port Orchard, Washington, is scheduled to hear opening arguments as early as today about whether Intuitive properly trained a physician who, in his first unassisted surgery using the company’s da Vinci surgical system, removed the prostate gland of a patient who later died. After seven hours of robotic surgery in September 2008, complications developed and the physician, Scott Bildsten, and other doctors turned to traditional surgery and then emergency care to repair a rectal laceration. The patient, Fred Taylor, died last August of heart failure resulting from injuries caused by Intuitive’s inadequate training of Bildsten, lawyers for Taylor’s family claim. Robot wows surgeons, but freak episodes include robot hand that won’t let go, arm that hits The biggest thing in operating rooms these days is a million-dollar, multi-armed robot named da Vinci, used in nearly 400,000 surgeries nationwide last year — triple the number just four years earlier. But now the high-tech helper is under scrutiny over reports of problems, including several deaths that may be linked with it, and the high cost of using the robotic system. There also have been a few disturbing, freak incidents: a robotic hand that wouldn’t let go of tissue grasped during surgery and a robotic arm hitting a patient in the face as she lay on the operating table. When Fred E. Taylor arrived at Harrison Medical Center in Silverdale, Wash., for a routine prostatectomy, he expected the best medical care new technology had to offer: robotic surgery, billed as safer, less painful and easier on the body than traditional surgery. The operation, on Sept. 9, 2008, was supposed to take five hours. But it was marred by a remarkable cascade of complications and dragged on for more than 13 hours, leaving Mr. Taylor, who had been an active 67-year-old retiree, incontinent and with a colostomy bag, and leading to kidney and lung damage, sepsis and a stroke. Intuitive Surgical Inc. (ISRG), the maker of surgical robots used in 367,000 U.S. operations last year, is facing accusations in lawsuits that it put patients at risk by marketing the machinery to doctors without providing adequate training. Company e-mails introduced in a lawsuit filed against Intuitive in Kitsap County, Washington, suggest salesmen lobbied hospitals to scale back doctor training. One manager’s e-mail lauded a salesman for persuading a hospital that five supervised operations were too many. In another, a manager told a sales team not to “let proctoring or credentialing get in the way” of meeting goals on the number of robot surgeries. Robot Surgery Risk Needs Disclosure as Injuries Rise A rising number of injuries linked to robotic surgery has been reported to Massachusetts health officials, spurring the state to call for better oversight on training and more disclosure to patients on potential risks. The state’s Board of Registration in Medicine said in a statement on its website yesterday that it has received “an increasing number” of reports of patient complications related to the surgery in the last two years. While the board doesn’t name any company, the only robot system cleared in the U.S. for soft tissue surgery is made by Sunnyvale, California-based Intuitive Surgical Inc. (ISRG) What Happens When the Surgical Robot Malfunctions? In a court deposition related to alleged da Vinci complications in one of his surgeries, Washington urologist Scott Bildsten said, "One problem you can run into is sword fighting—you're clanging your arms together and fighting each other, in which case they can build up unnecessary tension." Robotic Surgery: Growing Sales, but Growing Concerns In recent years, as the da Vinci's popularity has grown, so have questions and concerns about its safety, training and the aggressiveness of its marketing. Intuitive executives declined to be interviewed for this story, and a spokeswoman said the company would not comment on issues of safety, training and marketing because they are "within the context of active litigation." Statement on Robotic Surgery by ACOG President James T. Breeden, MD 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.... Patients should be advised that robotic hysterectomy is best used for unusual and complex clinical conditions in which improved outcomes over standard minimally invasive approaches have been demonstrated. Intuitive Robot Probe Threatens Trend-Setting Surgeries The safety of robots made by Intuitive Surgical Inc. is being probed by U.S. regulators, raising questions about the prospects of one of the hottest technologies in health care.... The surveys were sent to hospitals that belong to a product safety network overseen by the FDA. What the agency is trying to determine is whether a rise seen in incident reports sent to the agency are “a true reflection of problems” with the robots, or the result of other issues, said Synim Rivers, an agency spokeswoman, in an e-mail. “It is difficult to know why the reports have increased,” she said. Hospital websites don’t tell whole story on robot-assisted surgery Fewer than 5% of hospitals include information on the costs and complications of robot-assisted gynecologic procedures. Many sites feature emotion-laden marketing language. Hospitals hype robot surgery for women: study "Consumers shouldn't expect straight talk about robot surgery from hospital websites, but rather vague claims and marketing mantras, according to a new U.S. study.... The findings, published in the American Journal of Obstetrics & Gynecology, jibe with a report from last year that looked at how U.S. hospitals describe robot surgery in general on their websites. That study, in the Journal for Healthcare Quality, concluded that online materials 'overestimate benefits, largely ignore risks and are strongly influenced by the manufacturer.'" Robot Adds $6K to Prostate Surgery Cost "'Robotic-assisted radical prostatectomy (RARP) cost 60% more than an open procedure, a difference driven primarily by higher operating-room costs, according to data from one large medical center.... RARP volume has grown in the absence of data to demonstrate the cost-effectiveness of the surgery, said Tomaszewski [of the University of Pittsburgh]...." Hospitals Misleading Patients About Benefits Of Robotic Surgery, Study Suggests Johns Hopkins research shows hospital websites use industry-provided content and overstate claims of robotic success.
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