Addressing Intuitive’s second-quarter reporting, CNBC notes that Intuitive’s income target missed the mark by 10 percent for Q2, with sales lagging behind expectations by 9 percent. Defenders note that with continued financial pressure on hospitals, many are deferring the acquisition of a system that comes with a whopping $1.5 million price tag.However, critics note the growing chorus of concern over the potential for robot injury - concern that has now entered the realm of public conscience following the airing of a documentary in the spring, on CNBC, focusing on the formidable machine that hovers over a patient akin to a giant Transformer.
Doctors, for the most part have embraced the technology as allowing for an easier, more precise minimally invasive procedure that is quicker and allows for more rapid healing for the patient, thereby reducing bed pressures in hospitals. Today there are 450,000 surgical procedures per year in the US utilizing the da Vinci system.
Advocates also note that the reported incidents of da Vinci robot failure translate to a failure rate that is statistically insignificant.
Nonetheless, there have been da Vinci lawsuits alleging unnecessary injury. Some patients have died. CNBC (4/18/13) featured the story of Kimberly McCalla, a young woman who underwent a hysterectomy procedure aided by the da Vinci robot. The 24-year-old allegedly suffered a da Vinci robot injury and died 11 days after the procedure. Operative reports showed Kimberly suffered bleeding from a main artery into her pelvis. Her father has launched a da Vinci lawsuit.
There have been reports of electrical arcs during a procedure that have been alleged to injure adjacent tissue. In 2011, Intuitive, while taking pains to articulate they were not triggering a recall, notified all of its client hospitals that a new tip for surgical scissors had been designed and was forwarded to all hospitals using the da Vinci robot. Tips of an older design that were in stock but unused were to be returned.
Intuitive has been called to the carpet by the FDA for not following procedure and protocol over that design change and implementation.
However, beyond the promised precision that a computer-assisted system can provide is the potential for a systems failure that could potentially put a patient at risk.
While many surgeons have led the cheering section for da Vinci in support of increased surgical precision and hospitals chase the potential for fewer hospital patient hours, da Vinci is not for everybody and it has its critics.
Dr. Marty Makary is one of them. Makary, of the renowned Johns Hopkins University Hospital, co-authored a study cross-referencing the FDA adverse event reporting database (Manufacturer and User Facility Device Experience - or MAUDE ) with press reports and da Vinci lawsuits. According to CNBC, Makary found eight cases that were either incorrectly filed or never went into the database at all.
There have been 85 deaths and 245 injuries officially reported since da Vinci first appeared in 2000. While those numbers pale when compared against 1.5 million da Vinci procedures performed since 2000, Makary thinks there could be more.
But beyond reported da Vinci Robot injury is what Makary regards as “the lack of haptic [tactile] feedback,” during a surgical procedure, he told CNBC. “Because we’re working around major blood vessels, an inadvertent injury could result in a catastrophic bleed within seconds.” Makary, it should be noted, has been trained on the da Vinci robot. He is also a pancreatic specialist known for not shying away from complex procedures.
There have been various reports of unintended burn injuries to tissues from arcing. One patient profiled in the CNBC documentary, whose bladder was inadvertently burned, required lines directly into her kidneys in order to save her life. Other patients have allegedly suffered cuts and other injuries to organs and tissue. While the da Vinci system’s 3-dimensional camera offers unrivaled clarity during minimally invasive laparoscopic surgery, one surgeon profiled by CNBC noted that a surgeon’s field of vision is limited to what the camera is showing him. He cannot see what is going on just outside of the frame or behind, and if an aspect of the giant robot may be doing unintended harm to the patient beyond the surgeon’s field of vision, the surgeon remains unaware.