FDA Report Faults Intuitive Surgical Over the da Vinci System

fda_blames_intuitive_surgicalThe U.S. Food and Drug Administration (FDA) has criticized Intuitive Surgical, which manufactures and markets the da Vinci robotic surgical system.

According to the agency, Intuitive Surgical neglected to report the steps it took to protect patients from accidental electrical burns, wrote MedScape Medical News, citing an FDA inspection report issued May 30. The FDA inspected Intuitive Surgical’s Sunnyvale, California headquarters on a number of occasions during April and May.

Officials at Intuitive Surgical advised MedScape Medical News that it “implemented corrective actions” for this and other infractions that were cited in the FDA’s report.

Agency data indicates a 34 percent increase in incidents related to the da Vinci robotic surgical system and that some of these incidents were listed as fatal. Reports involved the period of time from 2011 to 2012. Also during that time, the number of da Vinci procedures that have been conducted in the United States increased by 26 percent, Intuitive Surgical said, according MedScape Medical News.

The FDA report indicates that Intuitive also failed to advise the agency of four “field actions” meant to “reduce the risk to health posed by a device.” In the first incident, Intuitive Surgical sent out a customer letter dated October 10, 2011 with instructions on the proper use of surgical instruments with insulating tip covers and on the correct electrical generators for monopolar cautery instruments. The letter, according to the FDA, came after complaints and medical device reports (MDRs) were filed with the agency over electrical arcing through damaged tip covers, which burned patient tissue, according to MedScape Medical News. During 2010 and 2011, Intuitive received 134 complaints concerning so-called “tip-cover issues” and filed 82 MDRs, according to the inspection report.

Intuitive neglected to advise the FDA that it sent a letter to its customers in October 2011, the agency said. That letter contained information associated with inspecting cannulas, which are used to insert instruments into patients’ bodies, according to MedScape Medical News. The FDA report also states that a source of injurious electrical arcing involves tip-cover damage caused by defective cannulas.

The agency also cited Intuitive for neglecting to advise the FDA that it had advised clients that the da Vinci system did not receive FDA approval for thyroidectomy procedures, yet promoted its robotic surgery technology for this procedure; da Vinci conducted transoral surgery, which was also not indicated for pediatric patients, MedScape Medical News reported. The device maker also neglected to document equipment design and five MDRs related with thyroidectomies, the inspection report indicated, according to 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 have resulted in death or chronic pain and disability. Lawsuits fault aggressive marketing tactics Intuitive used to convince hospitals to purchase the expensive surgical robot, and allege that a combination of design flaws inherent in the da Vinci, as well as poor physician training on the device, have led to significant injuries.

Some 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 that manipulate small tools that are inserted into the patient’s body via tiny incisions. The system also utilizes a small, lighted camera that displays the surgical area in 3-D video. The da Vinci is the only robotic surgery approved by the FDA for soft tissue surgeries.

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