Da Vinci Surgery Injuries on the Rise, FDA Surveys Doctors

Da Vinci surgery injuries have become a growing concern in recent years, as the da Vinci robot manufactured by Intuitive Surgical has increasingly been used as an alternative to traditional laparoscopic procedures.  The FDA conducted a survey earlier this year to obtain more information about the safety and effectiveness of the robot in response to a 34 percent increase in reports of adverse events from 2011 to 2012, some of which involved injury and death.

The results of this survey were released in November, and indicated that most surgeons were pleased with the da Vinci robot and reported “fewer patient complications and shorter hospital stays as a benefit of surgery.”  However, the sample size was very limited, with only 11 surgeons responding, and there are still remaining concerns about the use of the da Vinci to perform procedures, especially among certain patients.

Reports of Da Vinci surgery injuries are common

The da Vinci surgical robot was released in 2000 and is used in a variety of medical procedures including treating kidney cancer or kidney disorder; performing hysterectomies;  treating uterine fibroids; removing the prostate; treating throat cancer; endometriosis treatment; treating intrauterine bleeding; obesity reduction procedures and treating other gynecological or urological conditions.

The robot promised faster recovery time for patients, but unfortunately,with widespread use came a greater understanding of da Vinci surgery injuries.

Injuries that have been reported to the FDA and/or allegedly linked to the use of the robot include:

• Burns
• Uterine lacerations
• Vessel or organ punctures
• Intestinal tearing
• Death

The burns have been the most widely reported of the problems, with NBC News indicating that a series of lawsuits have been filed that “threaten to burst da Vinci’s high-flying bubble.”  An estimated 50 product liability lawsuits have already been filed, and an Intuitive Surgical report to the SEC indicated that even more complaints were likely.

FDA survey suggests physician concerns about da Vinci Robot

Amid the rising number of daVinci robot lawsuits, the FDA surveyed six physicians participating in the agency’s Medical product Safety Network (MedSun) as well as five additional surgeons who the agency selected on the basis of referrals.

Surgeons largely reported good experiences with the da Vinci robot, which is a computerized technology making it possible for a surgeon to view a procedure in three dimensions and manipulate robotic arms that control laparoscopic instruments even though the surgery is not an open surgery.

However, surgeons reported some limited product failings, many of which mirrored those described in adverse event reports that had been submitted to the FDA.  Reported problems included excessive collision of the arms of the robot, a drift in the robot’s arms during procedures, and electrical arcing of monopolar sheers that could cause burns. Doctors also indicated that the robot may not be appropriate to perform surgeries on obese patients.

Intuitive Surgical cautioned that the FDA survey could not serve as a basis to make scientifically valid conclusions because of its small sample size, pointing to “large clinical studies” that have documented the benefits of robotic surgery.