Robo-Surgeries Attract FDA Scrutiny


Not all surgeries are the same, and some operations might be better executed with robotic surgery than others.

In certain operations such as colorectal procedures, head or neck surgeries, and heart-valve procedures, some doctors describe being able to get into tighter spaces, benefitting from a greater degree of freedom the robotic hands afford them when compared to minimally invasive surgery.

The equipment is also expensive.

The only surgical robot on the market approved by the FDA is the da Vinci surgical system, made by Intuitive Surgical Inc. of California, with each unit costing roughly $1.45 million or more, and a hefty annual service agreement to the tune of at least $100,000.

More than 2,585 da Vinci Systems are installed in more than 2,025 hospitals worldwide, according to its website.

"The FDA routinely asks medical device companies and hospitals for information, clarification or additional data as part of post market surveillance," Intuitive Surgical said in a written response to ABC News. "Intuitive's highest priority is and always has been to provide patient benefit -- creating products that in a surgeon's hands are safe, effective and minimally invasive.

"Intuitive Surgical issued a statement on March 13, 2013 responding to questions about a recent rise in Medical Device Reports (MDR) filed by the company, which clarifies that it changed reporting practices and therefore saw an increase in MDRs (none involving reportable injury or death).

"For context, the da Vinci Surgical System has an excellent safety record with more than 1.5 million surgeries performed globally and total adverse event rates have remained low and in line with historical trends."

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