The Da Vinci Robot Surgical System is used in hysterectomies, prostatectomies, and other surgeries. Robot-assisted surgery is heavily advertised as a way to bring better results with an easier recovery, less pain, and fewer complications. Unfortunately, over 1,000 people have suffered from surgical mistakes, malfunctions, burns, electrocutions, organ damage, arterial perforation, and other serious complications.
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 issued a Class II recall of 30 da Vinci Surgical Robots because they may not have been tested adequately. 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 — Case report of a 65 year-old man who suffered permanent nerve damage during a robotic prostatectomy. 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.
- 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?
The Da Vinci Robotic Surgical System was developed by Intuitive Surgical, Inc. The first successful surgery using the system was performed in Belgium in 1997.
In 2000, the U.S. Food and Drug Administration (FDA) approved a Da Vinci surgical system with four robotic arms. Each arm has multiple robotic joints that enable the arm to rotate freely. The surgeon sits behind a console and moves specially-designed joysticks, which translate movement from the surgeon’s fingers to the instruments on the robotic arms. Instead of a large incision, minimally-invasive procedures are performed through several 1-2 cm “ports.”
One major benefit of robot-assisted surgery is reducing tremors (shakiness) in a surgeon’s hand while improving range-of-motion. Another benefit is 3D visualization of the surgical area, because the robot is equipped with double cameras that create a 3D image.
What risks are associated with the Da Vinci Surgical Robot?
- Surgeons could be pressured into using the device to help hospitals recover the costs.Hospitals are eager to have the latest high-tech surgical equipment. However, at a cost between $1 million and $2.25 million plus annual maintenance and replacement parts, hospitals need to perform many procedures to recoup the costs.
- Surgeons need to perform hundreds of procedures before they are truly proficient with a robotic surgical device. Many lawsuits allege that physicians were not properly trained on the proper use of the device, which may increase the risk of injuries for patients.
- The long-term benefits and risks of the Da Vinci surgical robot are still being evaluated. The use of robots in surgery is relatively new, and the risks, benefits, and complications are still being investigated.
- Surgical mistakes and malfunctions. The biggest disadvantage of robot-assisted surgery is the complete loss of tactile sensation and feedback. Extensive training is required to learn how to operate the system safely. The device uses a system of hand and foot pedals that must be operated while the surgeon is looking into viewfinders with a 3D image.
- Many Da Vinci robot surgery lawsuits have been filed alleging that surgeons are not properly trained to use the system before they begin operating on patients.
Da Vinci Robot Surgery for Prostatectomy
A prostatectomy is a type of surgery to remove the prostate gland for men who have prostate cancer. In the United States, more than 85% of all prostatectomies are performed with a surgical robot. According to this study published by the American Society of Clinical Oncology in January 2012, researchers warned about the risks of robot surgery for prostatectomies:
“Risks of problems with continence and sexual function are high … men should not expect fewer adverse effects following robotic prostatectomy.”
Da Vinci Robot Surgery for Hysterectomies
A hysterectomy is the surgical removal of the uterus. It is the most common surgery performed in the United States that is not involved with pregnancy. In recent years, the use of robots in hysterectomies has increased significantly. According to this study published in February 2013 in the Journal of the American Medical Association (JAMA), between 2007 and 2010, robot-assisted hysterectomies increased from 0.5% to 9.5% of all hysterectomies. Although the cost was significantly higher (about $2,189), patients had similar rates of blood-transfusion requirements and complications.
What is the Da Vinci Robot Surgery used to treat?
According to the Da Vinci Surgery Official Website, the system is marketed to treat the following conditions:
- 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
The following life-threatening complications and problems have been associated with the Da Vinci Surgical Robot:
- 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