Intuitive Surgical, maker of the da Vinci surgical robot, recently issued an “urgent medical device notification” to hospitals and other customers regarding “a potential issue” arising from the use of its da Vinci surgical robot.
According to the alert, some models of the da Vinci monopolar curved scissors have "micro-cracks" in them; these can create “a pathway for electrosurgical energy to leak into tissue during use and potentially cause thermal injury.” In bold type, the notification also revealed that the "micro-cracks may not be visible” even to the naked eye.
Intuitive Surgical does not even have an improved version of the scissors available yet. The company stated that it will inform its clients “immediately” as to when scissors “without the potential for micro-cracks are available for replacement.” Meanwhile, the company included in the notification a list of precautions and warnings for using the EndoWrist monopolar curved scissors. It also added that it had informed the U.S. Food and Drug Administration (FDA) of this action.
For Intuitive Surgical, the notification regarding the faulty scissors occurs in the face of a now-four-week-old trial charging the medical device maker with failing to properly train surgeon Scott Bildsten, who performed a robotic prostate removal on Fred Taylor, who died four years later, allegedly as a result of the da Vinci-assisted surgery, Bloomberg reported.
Intuitive’s da Vinci system is currently the only robotic surgical device approved by the FDA for use on soft tissue. According to Bloomberg, Taylor’s lawsuit is the first of at least 26 that have so far been filed against Intuitive over injuries allegedly caused by robotic assistance. Many of the suits are primarily over whether Intuitive properly trained surgeons on how to use the surgical robots.
The da Vinci is facing critics from other corners. According to a report in the Missoulian newspaper, the FDA is looking into a spike in reported problems based on a survey the agency provided earlier this year to surgeons who work with the da Vinci. An FDA spokeswoman told the Missoulian that, while such surveys are standard operating procedure, this particular one was in fact driven by concern over “the increase in number of [adverse event] reports received” about the da Vinci. At least five deaths have been included in reports filed about the da Vinci since early last year, the newspaper reported.
Also as a result of the seemingly mounting injury reports, in March of this year the Massachusetts Board of Registration in Medicine issued an advisory warning. In it, the state’s board cited medical complications—including bleeding, adhesions, and damage to the bowel and ureter—as well as one specific case in which a piece of forgotten rectal tissue was left inside a patient’s abdomen.