How Does the da Vinci Robotic Surgery Work?
The da Vinci surgical system uses robot-assist technology to perform complicated surgical procedures through a small incision. The system is operated by the surgeon through a console which controls the robot arm. After a small surgical incision is made, the surgeon inserts long, delicate instruments into area to be operated on. The tools include an endoscopic camera with magnification, lighting and temperature control on a control arm which allows the surgeon to see inside of the body. The camera along with other instruments such as a scalpel are manipulated through small hand movements on the control panel.
Because the surgery is being performed through a small incision rather than a large, open wound, there is much less bleeding and trauma than traditional surgery procedures. When compared to open surgery, da Vinci robotic surgery leaves a much smaller scar, may reduce the risk of infection through exposure to air, hands and surgical devices like suction and sponges and may reduce the overall recovery time after surgery.
|Device:||da Vinci Robotic Surgery|
|Manufacturer||Intuitive Surgical Inc.
|Uses:||Robotic-assisted surgery used for complex, minimally-invasive procedures
What Are the Drawbacks of da Vinci Surgery?
Da Vinci surgery may have revolutionized invasive surgery, but it has also created unique problems. With the only vision allowed through the endoscopic camera, the surgeon’s field of vision may be limited. This may impede the surgeon’s ability to maneuver and may result in a failure to identify additional issues that may have been obvious in another type of surgery.
The da Vinci robotic surgery system requires a period of training and may be difficult for some surgeons to become proficient at. This may be particularly true of older surgeons who are not accustomed to technologic advances. Consequently, the vast experience that more established surgeons have may be lost to the patient.
Da Vinci Surgery Side Effects & Complications
Robot-assisted surgical technology like the da Vinci robotic surgery system allows the surgeon to perform precise, complex movement through wrist movements using an electronic console. It was designed to reduce the risks inherent in a traditional open surgery by operating through a small incision; reducing infection risk, blood loss, and recovery time.
Unfortunately, robot surgery is not without risks and the da Vinci robotic surgery may cause serious side effects, complications and injuries.
|Complications of da Vinci Robotic Surgery|
Organ Tears & Perforations
The Da Vinci robotic system is considered by many to be one of the most astounding medical advancement of our time. The system allows surgeons to perform laparoscopic surgery using robotic instruments with movements that far surpass what the human hand can do. The robot features a camera, like other laparoscopic surgeries, but it also features a number of tools that are operated several feet from the patient via a console of controls. During the procedure, the surgeon does not touch the patient. Instead, he or she controls the arms of the robot that feature four robotic tools. The Da Vinci system has been used to perform prostate removal, hysterectomies, thyroid cancer removal, gastric bypass, and a variety of other surgical procedures.
Many patients have undergone robotic surgery procedures and have been happy with the results. Some find healing time is less and complications are fewer when using the robot, though this is a debated topic. Others believe robotic surgery methods offer no greater benefit than regular laparoscopic surgery. It is far more expensive and requires a great deal more training of surgeons, but the outcomes are not much different than a patient would experience with other surgical methods. Still others believe the surgery robot is dangerous and creates far too great a risk for patients to make any potential benefit worth it. There are a number of reported instances of injuries that back up the claims of the latter group.
Risks vary from situation to situation and depend on the training of the surgeon, the design and maintenance of the machine, and the particular needs of the patient.
Common complications include:
- Burns to arteries and organs
- Excessive bleeding
- Tears and punctures of organs, blood vessels, and arteries
Specific Cases of Organ Tears, Cuts, and Punctures
One of the worst complications associated with Da Vinci robot surgery is tearing and puncturing of internal organs. Many people attribute this to the fact that surgeons perform surgery while not actually touching a patient’s body. Small tears or punctures that would be noticed when a surgeon is “hands-on” go unnoticed because of this disconnect. Unfortunately, a small, easily repairable tear or puncture can turn into a serious problem if not treated and in severe cases, could be fatal.
There are several instances on record in which tearing and puncturing has occurred. Patients have experienced minor cuts near the surgical sites. Reports of punctured organs, including the uterus, have also occurred. One related event in 2009 in New Hampshire, when a patient undergoing hysterectomy surgery had both ureters cut. The injury went unnoticed during the procedure, but doctors realized there was a problem when she experienced renal failure after surgery. Several follow-up surgeries were needed to repair the damage, but she still experienced long-term damage and required life-long follow-up care.
Another incident took place in 2002 in Tampa, Florida occurred when a patient with kidney cancer experienced cutting of the inferior vena cava and the abdominal aorta. Mid-surgery, surgeons shifted from the Da Vinci system to traditional methods. It was during this time the cuts were noticed, but it was too late to save the patient, who died within 24 hours.
Patients have also received settlements when they sued the manufacturer of the Da Vinci surgery system because of their injuries. One settlement occurred in Alabama and alleged the faulty design of the machine resulted in severed ureters and bladder damage during a hysterectomy procedure. The second case was filed by the family of a deceased man in Chicago. The lawsuit claimed the man died as a result of his 2007 spleen removal surgery, performed by the Da Vinci robot. The man suffered two cuts to his small intestine during the procedure that went undetected and later became infected.
Bowel and Bladder Injuries
Bowel injuries may occur as a result of the type of electrical current used by the robot or because the robotic arm tears or perforates the bowel.
Symptoms from bowel injuries arise within a few days of surgery and include:
- Abdominal pain
- Nausea and vomiting
- Abdominal distension
Unfortunately, many patients have returned home by the onset of these symptoms and if not treated quickly, bowel injuries can be fatal.
Bladder injuries may be caused in the same way as bowel injuries but may be immediately noticed and repaired during the initial procedure.
If bladder injuries are not identified immediately, they may cause:
- Blood in urine
- Pelvic pain
Long term, patients may suffer from pain and sexual dysfunction.
Additional surgeries may be required to repair both bladder and bowel surgeries, putting the patient at additional risk for infection and surgical complications and a lengthy recovery time.
During uterine surgery performed by da Vinci robotic surgery, uterine puncture may occur. This may increase the complexity of the surgery and risk for bleeding. The robotic arm may also slip through the punctured uterus to injure other organs. In most cases, this injury will be noticed during the procedure.
Complications caused by perforation of the uterus may include:
- Conversion to traditional open surgery
- Increased infection risk
- Internal scarring
- Severe bleeding
- Increased anesthesia time
- Severe pain
- Lengthy recovery time
In addition to the potential for complications caused by da Vinci robotic surgery, there do not appear to be any improvements over uterine surgery performed through traditional laparoscopic procedure and the robot surgery is done at about twice the cost.
Use of the da Vinci robot surgery system may increase the patient’s risk for pneumonia. Researchers believe that as many patients who undergo hysterectomy or other da Vinci procedures are required to be in an angled head-down position, a buildup of fluid in the airways may increase the need for intubation. Intubation, along with the fluid collected in the airway increases the chance for infection to develop, resulting in pneumonia.
Symptoms of pneumonia may include:
- Deep cough
- Chest pain
- Difficulty breathing
- General feeling of illness
Da Vinci Organ Burns
Patients undergoing da Vinci robotic surgery have experienced perforations and tearing of other abdominal organs, along with internal burns caused by electrical current. These injuries result in significant injury, increased surgery and anesthesia time, internal scarring and may require conversion to traditional surgery which increases the risk for infection and bleeding.
Perforation, tearing and electrical burns may be caused by robot malfunction but may also be caused by improper use of the machine by inadequately trained surgeons. Training of surgeons is a significant issue and many surgeons have reported that they required more time than recommended in order to become proficient at use of the technology. Not all hospital facilities which have purchased the system are able to provide the training necessary for surgeons to feel comfortable with the equipment.
The US Food and Drug Administration has received numerous reports of injuries and fatalities related to surgery performed with the Da Vinci robotic surgery system. Though injuries range from punctured organs to developing pneumonia following surgery, one of the most common types of injuries is organ burns. Patients are being burned and electrocuted during surgical procedures, which is damaging blood vessels and organs and triggering uncontrolled bleeding. Many of these patients have needed emergency follow-up surgery and experience pain and complications, even after corrective procedures.
Robot Scissors Cause Burn Injuries
The manufacturer of the Da Vinci robot, the Intuitive Surgical, Inc., published a warning in May 2013 warning surgeons and patients of the risk associated with the electrical scissors (called EndoWrist Hot Shears Monopolar Curved Scissors) used during Da Vinci surgery. The electrical scissors are used to cut and cauterize tissue during procedures. The risk occurs when micro-cracks develop in the protective insulation and from electricity arcing and burning tissue outside the surgical area.
By July 2013 in response to issues with organ burns, the FDA issued a warning letter to Intuitive Surgical, Inc., informing them of problems noticed during inspections in the spring of that year. The company had already begun warning customers (hospitals and surgery centers) of the scissors issue because of complaints received from users. Other design defects were also noted in the reports, including cleaning procedures that led to sparking and tears in the protective covers of the scissors.
The monopolar scissors are used to perform electrosurgery. Like the other tools on the Da Vinci robot, the scissors are controlled by a surgeon via a console. An electrical current runs though the scissors and is used to cut, coagulate, and cauterize tissue during surgery. The problem occurs when an electrified part of the instrument touches one that is metal, but not electrified. The insulation is intended to create a barrier between the surfaces, but it has failed to do so during many procedures.
There have also been issues with user error. If an unpracticed surgeon fails to operate the Da Vinci robot properly, in can result in an unintentional firing of the electrical equipment. Basically, the electrical current is activated when it should not be. The combination of user error, insulation failure, and general mechanical malfunction has resulted in a number of serious injuries.
Robotic Surgery Burns Recorded in the FDA Database
The FDA’s database listed the following instances of injury related to Da Vinci robotic surgery burns:
- Prostatectomy procedure in which scissors flamed, sparked, and smoked at the joint when activated by the surgeon. The sparking and flames were accompanied by reports of a garlic odor.
- Hysterectomy procedure in which patient’s injuries proved fatal. Burning occurred to the right external iliac artery, which resulted in blood pumping into the body cavity. This caused bowel ischemia.
- Sparking of the scissors arced and sparks reached patient’s artery. There was visible charring.
- Prostatectomy procedure in which arcing caused the burning of tissue.
- Hysterectomy procedure in which blood vessels were burned and injuries proved fatal. Follow up procedures included blood transfusions and an emergency laparotomy.
Under-reporting of da Vinci Injuries and Deaths.
Researchers have found that the number of injuries and deaths associated with da Vinci robotic surgery systems may be under-reported. Over the course of 12 years the FDA received just under 250 report of incidents related to robotic surgery. Investigators later found additional instances that were reported in the media or elsewhere but were never officially reported to the FDA.
In more than one instance, injuries and fatalities reported to the FDA were not reported until several hundred days after the incident. In one case, it took 930 days after the surgery for the problem to be reported. Researchers acknowledge under-reporting is an issue with most medical procedures.
Injured by da Vinci Robot Surgery?
Many patients are happy with the results of their Da Vinci Robot surgery, but others have experienced serious complications resulting in serious medical injuries which may be long-term, debilitating and costly.
People who were injured or loved ones of those who died because of da Vinci robotic surgery may be eligible for compensation should seek legal assistance.
What Procedures Can Be Done with da Vinci Robotic Surgery?
The Da Vinci robotic surgery system is used for conditions that affect the soft tissue and organs. The FDA approval for the Da Vinci robotic surgery system includes: general laparoscopic surgery, gynecological surgery, urological surgery, general non-cardiovascular thoracic surgical procedures, and thoracoscopically assisted cardiotomy procedures.
Da Vinci can be used to treat:
- Kidney disorders
- Kidney cancer
- Bladder cancer
- Coronary artery disease
- Colorectal cancer
- Uterine disorders
- Gynecologic cancer
- Prostate cancer
- Throat cancer
- Mitral valve prolapse
- Uterine prolapse
- Uterine fibroids
Da Vinci Prostatectomy
When used for prostatectomy, the da Vinci robotic surgery system is intended to be a technological improvement over traditional “open” surgery. It uses robot-assisted technology which allow the surgeon to perform complex, precise movements through wrist action using an electronic console.
Until the da Vinci robot prostatectomy procedure was developed, patients with prostate cancer had only two options. Traditional surgery involved an open procedure which was performed through a large abdominal incision that ran from the umbilicus to the pubic bone. Laparoscopic prostatectomy was performed through small incisions through which an endoscopic camera and surgical instruments were inserted.
The development of the da Vinci system prostate removal surgery expanded the options to include robot-assisted surgery through a small incision, similar to laparoscopy. Though it was intended to improve patient outcomes, it still poses a number of similar risks and is much more costly than laparoscopic procedures.
Despite the continued risks and increased cost, more men are choosing to have da Vinci prostatectomy surgeries than any other treatment for the 1.8 million men who are diagnosed with prostate cancer each year.
Da Vinci Robot Prostatectomy Side Effects and Complications
Surgical treatment for prostate cancer usually involves removal of the entire prostate, which will affect sexual and urinary function in most patients. Da Vinci prostatectomy was intended to be less invasive, protecting the sensitive nerves that control these functions and decreasing the risk of other potential complications.
It has not however, offered improvement over regular laparoscopic procedures and may pose the same risks as open prostatectomy, particularly if obstacles occur during the da Vinci surgery.
Complications of da Vinci robot prostatectomy include:
Open surgery may hold a higher risk for significant blood loss, however severe bleeding may be a significant concern in a da Vinci procedure. It may be necessary for the surgeon to cut into veins or blood vessels in order to remove cancerous cells. This will create internal bleeding which must be controlled through cauterization, sutures or other methods.
Urinary incontinence may be expected immediately following Da Vinci prostatectomy. Two muscles are needed to maintain urinary control, one of which resides in the prostate. As the whole organ has been removed, the remaining muscle must be strengthened over time to perform the job on its own. Urinary control may improve over a period of months but may still be inadequate and lead to “dribbling”, weak stream and inability to stop urination.
Sexual dysfunction, or the inability to achieve or hold an erection, is a significant and bothersome side effect that may be experienced immediately following Da Vinci prostatectomy surgery. Sexual function in males is controlled by a delicate bundle of nerves which may be clipped, stretched or damaged during Da Vinci prostatectomy surgery. In some cases, it may be necessary to remove some of these nerves in order to remove all of the cancerous cells but in other cases, damage may be inadvertent. If the nerves have been only stretched or suffered minor damage, sexual control may be temporary but when they have been cut or required removal, inability to maintain erection naturally may be permanent.
Conversion to open surgery
In addition, if mid-surgery complications occur, the surgeon may be forced to abandon the da Vinci method and convert to a traditional open prostate removal procedure which will add to the risks of bleeding, infection, urinary incontinence and sexual dysfunction. This may occur due to machine malfunction or individual patient conditions.
Da Vinci procedures may take longer than regular laparoscopic or traditional open surgery and may require additional anesthesia time, furthering the risk of complications. This may result in an unfortunate need to convert the surgery method, furthering risk to the patient.
Prostate Cancer Surgery
Prostate cancer affects one in six men in America during their lifetime and 1.8 million men are diagnosed with it every year. It is not considered to be as life-threatening as other types of cancer and many men die of other natural causes, long before prostate cancer would become fatal. In the case of men whose prostate cancer may be considered aggressive or when the patient is concerned about progression of the disease, there are three main treatment options. These include only radiation, chemotherapy and prostatectomy.
Over the past several decades, men have undergone routine prostate cancer screening with a blood test which identifies markers of prostate cancer, however many experts believe screening has led to a large number of unnecessary treatments and prostatectomy procedures. Some medical professionals have advocated a change in the treatment of prostate cancer but da Vinci prostatectomy has become the most common prostate cancer treatment method. This may be due to aggressive marketing techniques on the part of the hospital.
Many patients have been informed that Da Vinci prostatectomy surgery is safer and faster. However, this is not always necessarily the case. Some experts have theorized that the hospitals are driving popularity of the Da Vinci robot surgery in order to help cover the high cost of the Da Vinci robotic system. A da Vinci robotic surgery system may cost upwards of $2 million initially and requires annual maintenance costing $100 thousand each year.
For patients, da Vinci robot prostatectomy is generally more costly than regular laparoscopic prostate removal. If complications occur and procedure conversion to open surgery is required, it becomes even more expensive.
Compensation for da Vinci Robot Prostatectomy Injuries
People or loved ones of those who have been injured or suffered complications due to a da Vinci prostatectomy surgery may be eligible for compensation and should seek legal advice.
FDA Recalls and Concerns About da Vinci Robotic surgery
In July of 2013, the Food and Drug Administration (FDA) issued a warning letter regarding the da Vinci robotic surgery system.
The letter stated that Intuitive Surgical, Inc. was subject to a number of violations including:
- Misbranding of device components due to improper labeling
- Refusal or failure to provide certain information
- Failure to submit reports regarding corrective actions
In 2015, the FDA noted that an increased number of adverse event reports had been received by the agency. Most of the reports involved complaints about device malfunction, mechanical issues, component breakage and computer display issues, however a number of the reports indicated severe injuries or even deaths that had been caused by the devices.
Da Vinci Robotic Surgery Cost
The cost of using the da Vinci robotic surgery system can be high. For the patient, it is not less expensive than other, but is generally $3,000 to $6,000 more than laparoscopic procedures. It becomes even more expensive if complications arise and additional procedures such as open surgery are required.
For the hospital or surgical center, the da Vinci system is a large expenditure. Each machine may cost upwards of $2 million, with yearly maintenance costs of $100 thousand or more and each surgeon is required to undergo extensive training which may be costly. It can take years for hospitals to recover the costs for investment in a da Vinci system. In addition, many of the surgical procedures which resulted in patient injury have cited improper training of the operating surgeon as a cause, making the hospital and surgeon at least partially liable for potential lawsuits.
Despite the challenges regarding costs and liability for injuries, Intuitive Surgical, the da Vinci manufacturer is selling more units and has upwards of $700 million in annual revenue. The company is still facing a number of lawsuits regarding injuries caused by the devices and as the number of da Vinci procedures continue to rise, additional lawsuits may be expected.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.