Unreported Injuries Caused by Robotic Surgery Complications
Written by James P. Nevin
Robot-assisted surgery may surprisingly be more dangerous than traditional surgery techniques. The problem is that the FDA does not know absolutely either way because injuries and deaths from using the da Vinci Robotic System are going underreported while patients continue to file products-liability lawsuits.
Hailed as the latest great technological innovation, health care professionals say the benefits of robot-assisted surgery include smaller incisions, shorter hospital stays, and less pain after the operation.
A study titled Underreporting of Robotic Surgery Complications was published earlier this year in the Journal for Healthcare Quality. The study searched through several databases and examined incidents involving Intuitive Surgical's da Vinci Robotic Surgical System over nearly 12 years. A total of 245 events were reported to the FDA during the study period, including 71 deaths and 174 nonfatal injuries. Researches found eight cases in which reporting fell short, including five cases in which no FDA report was filed at all. In the three incidents that were eventually reported to the FDA, it took an average of 20 months after the incident to file the report.
Hospitals are required to report when medical devices malfunction to the manufacturer, who then report the malfunctions to the FDA. Reporting device related complications to the FDA is paramount to consumer safety because the FDA assess and approves products based on these reports.
The use of surgical robots has grown significantly since 2000 when they were first approved for laparoscopic surgery (a type of surgery that uses smaller incisions than in traditional surgery) by the FDA. Between 2007 and 2011 the number of da Vinci systems installed increased by 75 percent in the United States from 800 to 1,400, according to the study.
Recently, Intuitive Surgical Inc., the maker of the da Vinci Robotic system has found itself in trouble with both the FDA, and embroiled in a number of lawsuits.
In July, Intuitive received a warning from the FDA after it found the company had failed to adequately report product corrections and patient adverse events.
Intuitive is currently being sued by its insurer alleging the company hid the number of legal claims it faced when it purchased product-liability insurance. Illinois Union Insurance Co. was informed by Intuitive that it had 25 claims during the policy application process. Intuitive failed to disclose that it had entered agreements with plaintiffs' attorneys to suspend deadlines for legal claims over its da Vinci system.
In an October 18 regulatory filing, the California-based company said it's defending around 50 product-liability lawsuits brought by patients who allege injures linked to robotic surgery.