FDA Reports Faults Intuitive Surgical over the da Vinci SystemJun 28, 2013
The U.S. Food and Drug Administration (FDA) has faulted device maker Intuitive Surgical, the maker of the controversial da Vinci robotic surgical system.
The agency says that Intuitive Surgical failed to report the measures it took to protect patients from suffering accidental electrical burns, according to MedScape Medical News, citing an FDA inspection report issued May 30. The FDA inspected Intuitive Surgical's Sunnyvale, California headquarters during April and May.
Officials at Intuitive Surgical advised MedScape Medical News that they had "implemented corrective actions" for this and other infractions cited in the FDA’s report.
Agency data also indicates that a 34 percent increase in incidents, some listed as fatal, has been associated with the da Vinci system from 2011 to 2012. During that time, the number of da Vinci procedures taking place in the United States increased 26 percent, according to Intuitive Surgical, reported MedScape Medical News.
The FDA report indicates that the device maker neglected to notify the agency of four "field actions" meant to "reduce the risk to health posed by a device." In the first incident, Intuitive Surgical sent a letter dated October 10, 2011 to its customers with instructions on the appropriate use of surgical instruments with insulating tip covers and on the correct electrical generators for monopolar cautery instruments. This letter, according to the FDA, followed complaints and medical device reports (MDRs) filed with the agency over electrical arcing through damaged tip covers that burned patient tissue, MedScape Medical News reported. In fact, Intuitive received 134 complaints concerning so-called "tip-cover issues" and filed 82 MDRs, during 2010 and 2011, according to the inspection report.
Intuitive also failed to advise the FDA that it sent a letter to its customers in October 2011 that contained information concerning inspecting cannulas used to insert instruments into the body, according to MedScape Medical News. The FDA report indicates that a source of injurious electrical arcing involves tip-cover damage caused by defective cannulas.
The FDA also cited Intuitive for not telling the agency that it had advised clients that the da Vinci system was never approved for thyroidectomies — even though it had promoted its robotic surgery technology for that very procedure. Additionally, da Vinci conducted transoral surgery, although it was not indicated for pediatric patients, MedScape Medical News reported. Intuitive also did not document equipment design and five MDRs related to thyroidectomies, according to the inspection report, said MedScape Medical News.
Personal injury lawsuits allege that the da Vinci robotic surgical system caused severe internal injuries, including burns, tears, and other complications, some of which have resulted in death or chronic pain and disability. The lawsuits fault Intuitive’s aggressive marketing tactics, and allege that a combination of design flaws and poor physician training have led to serious injuries.
About 89 deaths have been linked to the da Vinci robotic surgical systems since 2009. In robotic-assisted surgery, a surgeon sits at a console operating several robotic arms. The arms manipulate small tools that are inserted into the patient’s body via tiny incisions. The system uses a small, lighted camera that displays the surgical area in 3-D video. The da Vinci is the only robotic surgical system approved by the FDA for soft tissue surgeries.