FDA’s approval of the da Vinci surgical system for use in minimally invasive surgeries gave surgeons the capability to perform surgeries with the highest precision and accuracy and hospitals, a higher level of quality care for patients. The da Vinci surgical system, a multi-armed robotic surgical device, is, thus far, the only surgical system that has been certified by the US Food and Drug Administration (FDA) to carry out soft-tissue surgical procedures. Its manufacturer, Intuitive Surgical Inc., is an American firm located in Sunnyvale, California.
The device is most commonly used in procedures like removal of gallbladders, cancerous bladders and prostrates, shrinking of the stomach, heart valve repair, organ transplant, cystectomies, ureteral reimplantation and reconstruction of new bladders. The device is operated by a qualified or trained surgeon who is positioned a few feet from the operating table. The da Vinci provides him/her with an enlarged image of the surgical site, while its other arms, which are capable of 360 degrees movement and tipped with the necessary (detachable) instruments, perform the surgical procedure through his/her command (via the use of a console).
Unlike in open (or invasive) surgery, where the surgeon makes incisions as long as four inches to enable him/her to reach into the patient’s internal organs, the da Vinci device, in minimally invasive surgeries, needs only to make tiny holes, a few millimeters in length, which are big enough for the endoscope and the instruments to go into. Though there may be multiple incisions, their small sizes account for less loss of blood, very small stitches, less pain, quick patient recovery and reduced hospital bills due to shortened hospital stays. More than all these, however, what made many surgeons celebrate the da Vinci is its capability for precision and zero probability for infection (surgical site infection is the cause of many patient deaths, claiming more than a hundred of thousand lives annually in the US).
The capability of the da Vinci device has won the interest of many hospital in the US, Europe and Japan. Thus, in the mid of 2013, Intuitive Surgical Inc. said that it has already sold at least 2,000 units to hospitals around the world and that the number of surgeries where the machine has been used has reached more than half a million.
It seems, however, that with the increase in the number of successful surgeries is the increase in the amount of accidents that are claimed to be caused by the machine. Besides mechanical failure prior to the start of surgery, there are also reported cases of burns, internal bleeding, tears, infection or sepsis and wrongful death. Because of these accidents, many people have hired da Vinci surgical robot lawyers and filed suit against Intuitive. Some of the specific cases reported include:
- Death of a patient whose blood vessel was accidentally cut by the device during a hysterectomy in 2012
- A patient who died after a spleen surgery in 2007
- Perforation of a colon during a prostate surgery
- One of the robot’s arms not letting go of a grasped tissue during a colorectal surgery
- One of the robot’s arms hitting the face of the patient during a hysterectomy
Many surgeons claim that it would take more than a dozen (some say more than a hundred) surgeries before one would finally be totally comfortable using the da Vinci. Training is held for only two days and, though, assisted by another expert surgeon during an actual surgery mistakes may really be bound to happen.
But such premise only leads to the question: Is the cause of adverse effects really the device or the lack of experience by the surgeon? Investigations that will really determine the reason behind the adverse effects are still being conducted; in the meantime, hospitals with the da Vinci continue to be flocked by patients who need to undergo surgery and they all want to be operated on using the machine.