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Robotic surgical system revenues down; FDA probe continues

While the U.S. Food and Drug Administration has been investigating adverse-event reports associated with the use of the da Vinci Surgical System, the robotic surgical system's manufacturer, Intuitive Surgical Inc., has reported an anticipated decline in da Vinci's second-quarter revenue.

"Preliminary second quarter 2013 da Vinci Surgical System revenue is expected to decrease approximately 6 percent to approximately $215 million from $229 million during the second quarter of 2012," Intuitive reported in its July 8 statement. "The decline in U.S. system sales was impacted by several factors, including, among other things, increased economic pressure on hospitals, which in turn caused some to defer da Vinci System purchases, and moderating growth in our benign gynecologic procedures."

It would appear that Intuitive quarterly revenue and da Vinci surgery lawsuit filings have been inversely related. The lawsuits, among several claims, have alleged that Intuitive either knew or should have known about defects associated with an increased risk of patient injury and should have both corrected the problem and properly warned about the injury risks.

The da Vinci Surgical System, which the FDA approved in 2000, helps surgeons to perform cardiac, thoracic, urologic, gynecologic, pediatric, general, and transoral procedures by allowing them to remotely control the system's four robotic arms. Surgeons use a three-dimensional viewer to see what they are doing.

Federal regulators have documented in their inspection reports several da Vinci problems about which the manufacturer knew but failed to disclose to the proper FDA authorities - facts that many da Vinci surgery lawsuits will not overlook.

Following its two-month inspection ending May 30, the FDA cited the corporation for briefing clients but not briefing regulators about:

  • Ways to address electrical "arcing through damaged tip covers" that caused patient injury
  • Complaints related to thyroidectomies that were performed in accordance with Intuitive promotion, even though the system was "not cleared for thyroidectomy indication"
  • Apparent health risks related to the proper inspecting and flushing of surgical instruments
  • A clarification that da Vinci was not cleared for pediatric transoral surgery, which meant that previous device instructions posed a health risk to pediatric patients

Moreover, many da Vinci surgery lawsuits can be traced to defects pinpointed in adverse-event reports submitted to the FDA, which triggered the agency's 2013 safety probe.

In its report to investors, the stock commentary website Citron Research tracked da Vinci surgery adverse-event reports stored in the FDA's Manufacturer and User Facility Device Experience Database, or MAUDE.

"MAUDE data," the FDA wrote, "represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996."

Citron's report explained, "There are over 4,600 records in MAUDE which result from adverse events from Intuitive Surgical's da Vinci robot device. The outcomes range from the non-event (error code detected when no surgery was in progress) to severe injuries and deaths. About 3,900 of these records, or about 82 percent, are from years 2007 to 2012. ... There are 89 records that document the result of death of the patient."

Citron noted an abundance of adverse-event reports in which information was oddly scarce following legal inquiries, writing, "We see many cases in which, as soon as the risk of legal liability emerges in a case, the hospital stops providing further information about the patient outcome and post-failure inquiry findings."

Da Vinci surgery victims who are entitled to compensation need counsel who will persevere through the lack of prompt disclosure and fight hard so that justice may be served. The medical device attorneys at Reich & Binstock have considerable expertise in handling complex medical device litigation, such as a da Vinci surgery lawsuit, and they are willing to investigate at no charge any and all legal options that an injured da Vinci surgery patient may have. All one must do is decide not to be a silent victim and contact the law firm either toll-free at 1-866-LAW-2400 or online through the case evaluation request form posted on this website.

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