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As Injury Rates Increase, FDA Inquiry into Intuitive Surgical’s da Vinci Robot


The Food and Drug Administration is curious whether robotic surgery is helping patients or raising the cost of healthcare.

Intuitive Surgical’s da Vinci robot is the subject of an FDA survey that has been sent to key hospitals that belong to a product safety network overseen by the FDA.

Part of a robotic surgery device.

Surgeons will be asked about any complications that have resulted from the da Vinci robot. The FDA also wants to fine-tune which procedures are best suited for robotic surgery and conversely, which are not, reports Mass Device.

The Intuitive da Vinci is used to perform hysterectomies and, according to the FDA, reports of injuries are on the increase. In these times of medical cost awareness there is some doubt whether the $1.5 million da Vinci cost justifies the number of procedures.

A report just published in the Journal of the American Medical Association found that robot surgeries raise the price of a procedure roughly $2,200.

Advertised as being less invasive, the da Vinci is also used to repair torn heart valves without having to open a patient’s chest.

Originally the device was developed to use during battlefield conditions or to save lives in a biological or chemical attack. The physician operates a console several feet from the patient and maneuvers the mechanical arms equipped with surgical tools.

There were about 500,000 procedures utilizing the da Vinci last year, according to a report in Bloomberg.

Adverse events have included damage to the bowels and ureters, burns, as well as a broken instrument that fell into a patient. Intuitive blames the complications on user errors.

One surgeon interviewed by Bloomberg says the obvious problem with robotic surgery is a lack of tactile feedback, in other words, you can’t feel what you are doing.

In January 2008 the FDA recalled instruments used by the da Vinci Surgical System because they were leaving particulate matter in the patient.

That hasn’t hurt Intuitive, a Sunnyvale, California-based company, that has based most of its $2.2 billion in revenue in 2012 on the surgical robot. The company says any injury reports are extremely small and deny the adverse event reports have grown over time.

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