The Da Vinci Robotic Surgical System is marketed as a technologically advanced device for hysterectomies, prostate surgery, and more. The manufacturer claims it will bring better results with fewer side effects, less pain, and a shorter recovery time. Instead, over 1,000 people have been injured by mechanical malfunctions, burns, electrocutions, surgical errors, lacerations, arterial perforations, and more.
UPDATE: Robotic Surgery Linked to 144 Deaths Since 2000
July 21, 2015 — A recent study of adverse events submitted to the FDA has found 144 deaths and 1,391 patient injuries associated with the use of surgical robots since 2000. Click here to read more.
November 5, 2014 — Doctors are warning that women who undergo a hysterectomy or fibroid surgery with the Da Vinci Surgical Robot are usually treated with a morcellator, which is a surgical tool that can potentially spread undiagnosed cancer. Click here to read more.
October 15, 2014 — A study has linked robot-assisted ovarian surgery with higher costs and rates of complications compared to laparoscopic surgery. Click here to read more.
October 6, 2014 — The Oregonian reports that a lawsuit has been filed by a woman who was severely injured when the arm of a surgical robot was left inside of her abdomen after surgery. Click here to read more.
July 24, 2014 — Using robotic surgery to treat bladder cancer does not reduce the risk of complications, shorten hospital stays, or improve recovery time compared to traditional “open” surgery, according to a study of 118 patients that was published in the New England Journal of Medicine. Click here to read more.
July 10, 2014 — A study published in JAMA Surgery has found higher patient safety hazards from 2003-2009, soon after the Da Vinci Surgical Robot was adopted in clinical practice — especially in teaching hospitals. Click here to read more.
May 7, 2014 — The Journal of Clinical Oncology has published a study linking robot-assisted prostate surgery to significantly higher rates of genitourinary complications and miscellaneous complications than traditional open surgery. It was unclear whether these risks outweighed the benefits, including fewer blood transfusions, less blood loss, and shorter hospital stays. Click here to read more.
April 7, 2014 — Intuitive Surgical has initiated a recall (PDF) for a cannula (tube that is used to insert or remove fluid) that is used with the da Vinci Surgical Robot after receiving 98 reports of damaged devices and one patient injury. Customers should visually inspect the recalled cannulae for cracks, broken welds, and other defects. Click here to read more.
December 6, 2013 — Intuitive has recalled about 1,400 components that may cause friction in the robotic arm. If a surgeon pushes through the resistance, the arm could stall and suddenly catch up, resulting in an imprecise cut. Click here to read more.
September 11, 2013 — Study finds that delayed reporting of robotic surgery adverse events may under-estimate actual risk of complications. Click here to read more.
September 10, 2013 — New concerns on robot surgery complications. Click here to read more.
September 5, 2013 — Although more than 1 million robotic surgeries have been performed, a new study has found less than 300 reports of complications (including 71 deaths) in the FDA adverse event database. This suggests severe under-reporting, which could under-estimate the actual number of robotic surgery injuries. Click here to read more.
July 22, 2013 — Intuitive Surgical has reported in an SEC filing that they are facing 26 robot surgery lawsuits filed by individuals who were injured. They are facing no robot surgery class action lawsuits involving personal injury. Click here to read more.
July 19, 2013 — The FDA has sent a warning letter to Intuitive for warning customers about design defects and the dangers of robotic thyroidectomy in October 2011, before notifying regulators. Click here to read more.
July 19, 2013 –– Intuitive Surgical has lost 32% of their market value — about $6 billion — since February 2013 amid concerns about robot surgery injuries, costs, recalls, and more. Click here to read more.
July 15, 2013 — Intuitive Surgical has recalled 30 da Vinci Surgical Robots because they were not tested properly. Click here to read more.
June 20, 2013 — The first Da Vinci Surgical Robot lawsuit to go before a jury has returned a verdict in favor of the defense. However, the individual circumstances of the case mean that the verdict may not affect at least 30 other lawsuits currently pending against Intuitive Surgical. Click here to read more.
June 18, 2013 — A 65 year-old man suffered permanent, debilitating nerve damage after he underwent a robotic prostatectomy for more than 6 hours. Click here to read more.
May 13, 2013 — Intuitive Surgical has issued an “Urgent Product Notification” to warn that the electrical scissors used to cut and cauterize tissue can have “micro-cracks” in the insulation which may allow electricity to arc and burn patients outside the surgical area. Click here to read more.
March 22, 2013 —
- OB/GYN experts warn that Da Vinci Robot Surgery is not the best choice for most hysterectomies. Click here to read more.
- Intuitive Surgical has received 4,600 adverse event reports associated with the Da Vinci Surgical Robot. Click here to read more.
- Experts are concerned about “aggressive and misleading” marketing of the Da Vinci Surgical Robot. Click here to read more.
- FDA published case reports of malfunctions and injuries caused by Da Vinci Surgical Robot. Click here to read more.
- Numerous studies link Da Vinci Surgical Robot to malfunctions during surgery. Click here to read more.
What is the Da Vinci Robotic Surgical System?
Intuitive Surgical, Inc. developed the Da Vinci Robotic Surgical System in the 1990s. When the U.S. Food and Drug Administration (FDA) approved the device in 2000, it was the first robotic system approved for general laparoscopic surgery in the U.S.
The Da Vinci robot consists of four robotic arms with multiple joints and surgical instruments. The arms are controlled by a surgeon at a console who operates a joystick and foot pedals. The robot also has double cameras that create a 3D image of the surgical area, which the surgeon watches through a special viewfinder.
One major benefit of the surgical system is that procedures are performed laparoscopically (also known as “keyhole surgery”). Instead of one large incision, procedures are performed with robotic instruments guided through 1-2 cm “ports.”
What risks are associated with the Da Vinci Surgical Robot?
- Because the Da Vinci robot surgery is relatively new, the long-term risks, complications, and benefits are unknown. However, preliminary studies of hysterectomies and prostatectomies suggest that the device is no more effective than traditional surgical methods, but costs are substantially higher.
- Robotic surgical devices are very expensive, and hospitals could be pressured into using it on many procedures to recoup costs. Each device costs between $1 million to $2.25 million. Annual maintenance and replacement parts can cost hundreds of thousands of dollars per year.
- Surgeons must perform hundreds of procedures before they are proficient at using the device. Unfortunately, many lawsuits allege that patients were injured because their surgeon was not properly trained.
- Surgeons operate with no tactile sensation or feedback. The physician is removed from the operating table and must rely entirely on robotic controls to perform the procedure.
Da Vinci Surgical Robot for Prostatectomy
A prostatectomy (surgical removal of the prostate gland) is usually required for men who are diagnosed with prostate cancer. Today, more than 85% of all prostatectomies are performed with a surgical robot in the United States. Unfortunately, in January 2012, the American Society of Clinical Oncology published a study regarding risks associated with robot-assisted prostatectomies:
“Risks of problems with continence and sexual function are high … men should not expect fewer adverse effects following robotic prostatectomy.”
Da Vinci Surgical Robot for Hysterectomies
Hysterectomies (removal of the uterus) is the most common non-pregnancy surgery in the United States. In recent years, the use of the Da Vinci robot for hysterectomies has increased dramatically. According to a study published in February 2013 in the Journal of the American Medical Association (JAMA), robot-assisted hysterectomies increased from 0.5% to 9.5% of all hysterectomies between 2007 and 2010. Researchers found that women who had robot-assisted hysterectomies had similar blood-transfusion requirements and complications. However, the cost of the hysterectomy was an average of $2,189 more expensive.
What is the Da Vinci Robot Surgery used to treat?
Intuitive Surgical advertises the Da Vinci Robotic Surgical System for a wide variety of procedures, according to the official website:
- Gynecologic cancer
- Kidney cancer
- Prostate cancer
- Throat cancer
- Colorectal cancer
- Heart surgery
- Mitral valve prolapse
- Coronary artery disease
- Gynecological procedures
- Heavy uterine bleeding
- Uterine fibroids
- Uterine prolapse
- And more
Da Vinci Robot Surgery Complications and Problems
Some of the most serious, life-threatening complications associated with the Da Vinci Surgical Robot include the following:
- Surgical mistakes
- Tears to arteries
- Organ perforation
- Lacerated arteries
- Infection or sepsis
- Internal bleeding, hematomas
- Need for additional surgical procedures to correct mistakes
- Wrongful death