As Robot-Assisted Surgery Expands, Are Patients And Providers Getting Enough Information?

Today's post is shared from kaiserhealthnews.org. The use of robotic surgical systems is expanding rapidly, but hospitals, patients and regulators may not be getting enough information to determine whether the high tech approach is worth its cost. Problems resulting from surgery using robotic equipment—including deaths—have been reported late, inaccurately or not at all to the Food and Drug Administration, according to one study. The study, published in the Journal for Healthcare Quality earlier this year, focused on incidents involving Intuitive Surgical’s da Vinci Robotic Surgical System over nearly 12 years, scrubbing through several data bases to find troubled outcomes. Researchers found 245 incidents reported to the FDA, including 71 deaths and 174 nonfatal injuries. But they also found eight cases in which reporting fell short, including five cases in which no FDA report was filed at all. The FDA assesses and approves products based on reported device-related complications. If a medical device malfunctions, hospitals are required to report the incident to the manufacturer, which then reports it to the agency. The FDA, in turn, creates a report for its Manufacturer and User Facility Device Experience database. The use of surgical robots has grown rapidly since it was first approved for laparoscopic surgery (a type of surgery that uses smaller incisions than in traditional surgery) by the FDA in 2000. Between 2007 and 2011 the number of da Vinci systems installed increased by 75 percent in the United...

[Click here to see the rest of this post]

Found on

Related articles

• Leading Coal Industry Law Firm Withheld Evidence of Black Lung Disease (workers-compensation.blogspot.com)
• The Robotic Workforce (workers-compensation.blogspot.com)
• F.D.A. Shift on Painkillers Was Years in the Making (workers-compensation.blogspot.com)
• US Inspector General Wants More Disclosure By Back Surgeons Who Implant their Own Devices (workers-compensation.blogspot.com)
• Spinal fusions serve as case study for debate over when certain surgeries are necessary (workers-compensation.blogspot.com)
• FDA Proposes Changes in Pain Medication Prescriptions (workers-compensation.blogspot.com)
• What If I May Need Surgery Later? (workers-compensation.blogspot.com)
• Medical Device Litigation: Medtronic, Inc. v. Stengel (workers-compensation.blogspot.com)

Robot Surgery Damaging Patients Rises With Misleading Marketing

Many injured workers' require surgical intervention. Safety in these procedures is questioned. Today's post was shared by votersinjuredatwork and comes from www.claimsjournal.com

Porter Adventist Hospital in Denver announced last year that Warren Kortz, a general surgeon on the medical staff, was the first in the Rocky Mountain region to use a technique known as robotic surgery to remove gall bladders through one incision in the belly button. The operation, performed while the doctor sits at a video- game-like console, was “taking advantage of another breakthrough in robotic surgery” and is “easier on the patient,” the hospital said in a press release. “It’s Star Wars stuff,” Kortz was quoted as saying in another article put out by the hospital touting another operation, robot-assisted parathyroid surgery, in 2010. “My prediction is it will eventually replace everything else.” What the hospital and Kortz didn’t reveal was the risk. Even as Kortz promoted robotic surgery, 10 patients he treated suffered injuries or complications between 2008 and 2011, according to an April complaint by the Colorado Medical Board. Five had arteries punctured or torn. Objects were temporarily left inside two, and others had nerve damage. One died and another needed cardiopulmonary resuscitation. The complaint charges Kortz with 14 counts of unprofessional conduct, including sometimes not advising patients on alternatives to the robot. Robotic surgeries are on the rise, fueled by aggressive marketing by doctors, hospitals and Intuitive Surgical Inc., which manufactures the $1.5 million robot. Advertising on...

[Click here to see the rest of this post]

Found on

Related articles

• New Concerns on Robotic Surgeries (workers-compensation.blogspot.com)
• What If I May Need Surgery Later? (workers-compensation.blogspot.com)
• The Shocking Truth About Medication Errors (workers-compensation.blogspot.com)
• Nurses Prone to Injuries With Heavier Patients (workers-compensation.blogspot.com)
• An "F" for Quality (workers-compensation.blogspot.com)
• Many Cancer Patients Overtreated In Final Days (workers-compensation.blogspot.com)
• Mets' Harvey Is Covered Like Any Other Employee With a Workplace Injury (workers-compensation.blogspot.com)

New Concerns on Robotic Surgeries

Today's post was shared by WCBlog and comes from well.blogs.nytimes.com

A technologist with the da Vinci surgical system, which has been criticized in a series of reports. Mike Spencer/Wilmington Star-News, via Associated PressA technologist with the da Vinci surgical system, which has  been criticized in a series of reports. In early March 2009, Erin Izumi, a woman in her 30s from Tacoma, Wash., underwent robotically assisted surgery to treat endometriosis. The operation at St. Joseph Medical Center dragged on for nearly 11 hours. Ten days later, Ms. Izumi was rushed to an emergency room, where doctors discovered that her colon and rectum had been torn during the operation. She was hospitalized for five weeks, undergoing a series of procedures to repair the damage, including a temporary colostomy, according to her attorney Chris Otorowski. But even though medical device manufacturers and hospitals are required to report every device-related death and serious injury to a database maintained by the Food and Drug Administration within 30 days of learning about an incident, no report about the case was made in 2009. Hospital officials declined to comment, and a spokeswoman for the manufacturer said it became aware of the incident only when Ms. Izumi filed a lawsuit. It disputed the claim and settled the case in May 2012. That was not the only lapse in reporting problems with robotic surgical equipment, a new study has found. The equipment, called the da Vinci system, is made by Intuitive Surgical Inc. of Sunnyvale, Calif. It has been on the...

[Click here to see the rest of this post]

Related articles

• Claims Adjuster, TPA Could Face Criminal Charges for Worker Fatality (workers-compensation.blogspot.com)
• Tacking Health Care Costs Onto California Farm Produce (workers-compensation.blogspot.com)
• Has the Internet Raised or Lowered Healthcare Costs? (workers-compensation.blogspot.com)
• NFL moving closer to using helmet sensors (workers-compensation.blogspot.com)
• Procter & Gamble Eliminating Phthalates, Triclosan from Products Worldwide (workers-compensation.blogspot.com)
• On Access and Accountability - Two Supreme Court Rulings on Generic Drugs (workers-compensation.blogspot.com)
• Special Counsel Reports Concerns about Mississippi Veterans Hospital to the White House and Congress (workers-compensation.blogspot.com)