Defective Surgical Device: da Vinci Robotic Surgical System

If you need a surgical procedure such as a hysterectomy or a prostatectomy, the standard used to be that a surgeon would make a large incision and enter your body with a variety of instruments to perform the operation that removed your uterus or prostate. Although effective, these operations usually had long recovery times and included great pain and blood loss due to the size of the cut and the amount of time the body had to remain open. The risk of infection was also high.

Nowadays, however, these procedures and many others can be done differently. Rather than a surgeon standing over the patient, he or she can sit at a console, viewing the patient’s anatomy on a computer screen and performing all steps of the operation through the hands of a medical robot. Called the da Vinci Surgical System, this set of instruments allows the surgeon to have complete control over the procedure while decreasing the size of the incision, the possibility of an error from a shaking hand, and the likelihood of infection from a larger open wound. It allows a faster recovery time and less pain. Its precision of movement is unparalleled. Basically, the da Vinci system aims to give the experience of an open operation through a minimally invasive one, which sounds like a clear improvement on both open operations and laprascopy.

Unfortunately but perhaps predictably, the da Vinci Surgical System is not without flaws. The latest report from Intuitive Surgical, the makers of da Vinci, suggests that a malfunction in some versions of the Hot Shears Monopolar Curved Scissors (MCS) Instrument is causing microscopic cracks near the tip of the instrument, which allows electrosurgical energy to leak out during surgery and thermally injure surrounding tissue. For example, during a routine prostatectomy, the bladder is inadvertently burned by electricity coming through the infinitesimal crack in the MCS casing. Intuitive Surgical has tested the device itself and claims that no problems were found, but it does recommend that the MCS only be used ten times before replacing it, to prevent wear and tear from causing malfunctions. In its notification from May 8th of this year that documents the possible problem, it also lists a series of instructions meant to help avoid any issues, such as not to apply any energy to the tip of the MCS when it isn’t touching any tissue.

To understand what this really means, it is necessary to understand the basics of the da Vinci system. To use the robot to perform surgery, the surgeon sits at the console, which contains a screen displaying a highly magnified 3D image of the patient’s insides. The master controls on the console are moved around like forceps, and that is how the surgeon makes all movements during the operation. The patient cart, which is next to the patient, has four interactive robotic arms, including up to three EndoWrist instruments and the 3D camera that sends the patient’s image back to the console screen. The MCS is one of the many EndoWrist tools that the surgeon can use during the operation, inserting it into tiny, dime-sized incisions to cut when necessary. Due to the delicate nature of these operations, obviously it is hugely problematic to think that the MCS could have electrical force arcing out of it and into the patient’s body.

Although this system has been approved by the FDA, has been around for ten years, and is in widespread use throughout the country—it was used in around 400,000 surgeries in the past year—it has given many medical professionals pause due to its high cost, the 89 deaths attributed to it since 2007, and a handful of freak accidents, such as the time it failed to respond to commands to let go of tissue it was holding and had to be shut down in order to free the patient. There have also been reports of more horrific complications, such as the woman whose intestines fell out of her vagina five weeks post-hysterectomy due to an improperly closed hole where her cervix had been. Because the da Vinci system costs about $1.7 million, in addition to the costs of the hours spent training doctors on how to use it, hospitals that have invested in it market it heavily to their patients because they need to recoup their initial investment. This has left some doctors wondering whether they are pushing something that has not been proven by the research to be the best option.

The FDA is now looking into whether the incidence of problems linked to the da Vinci system have truly increased, whether reporting has improved due to doctors being more aware of and willing to report problems now that they’ve used the system more, or whether the seemingly increased problems are due to increased usage of the system. The question of whether surgical complications are more common with robotic than with other types of surgery is certainly going to be a difficult one to answer. It is important to note, too, that some surgeons feel that the da Vinci system is still safer than the alternatives, even given these reports. Dr. Rosanne Kho, for one, a gynecological surgeon from the Mayo Clinic in Arizona, says that all surgeons there know of potential issues but still feel more comfortable with using the robot. “We are very aware of this possible complication. We are not currently thinking that the robot would inflict more complications compared to the laparoscope.”

It should be noted that Intuitive Surgical, who has filed most of the reports, says there is no actual increase in complications or deaths due to the robot’s use. They do believe that the increase is due to changes in their reporting structure. But Dr. Marvin Markary, a surgeon at Johns Hopkins University in Maryland, is co-author on a paper that claims the opposite. He thinks that problems are actually underreported because many people don’t know how to properly evaluate robotic surgery. He also believes that marketing companies are the driving force behind the increase in robotic surgeries, which doesn’t necessarily have patients’ best interests at heart.

Also disturbing is the fact that there is no consensus within the medical community or from Intuitive Surgical itself about how many hours of training on the robot are required to make a surgeon competent to perform a particular operation. Physicians from Intuitive Surgical do train other surgeons on how to use the system at their facility in Sunnyvale, California and also insist that they take an online class to learn all of the vocabulary that is da Vinci specific, but all training is general and not related to specific operations or procedures, making it difficult to decide in some cases whether the da Vinci system is needed or is overkill. In the end, it is up to each individual hospital to determine whether their surgeons are ready to operate on a person using the robotic system.

Hospitals are also feeling the pressure to have the latest technology so that they can get the newest doctors, the best of the surgeons coming out of medical school, to come to their hospitals. But as Dr. Matt Smith, an obstetrician and gynecologist at Hamilton Medical Center in Dalton, Georgia, says, “Marketing in medicine, it’s kind of a scary thing. I think it’s up to the surgeon to explain to the patient what the expectations are. You may have somebody that’s not a good candidate for the robot.” In other words, the robot shouldn’t be used just because it’s there. It should only be used when doing so demonstrates a clear benefit to the patient. Right now, in the case of many of these types of surgery, there is no consensus on when that is.

We would like to review any cases involving an individual who has been injured during a surgery that used the da Vinci Surgical System. These include all different kinds of surgery such as gynecological, urological, colorectal, cardiac, thoracic, and head and neck surgeries.