Warning issued for potentially defective robotic surgery equipment

Intuitive Surgical is the manufacturer of the da Vinci robotic surgical system. Using this system, surgeons use a console in order to perform a surgery with the system’s robotic arms.

Over the years, the popularity of the system has increased with more and more hospitals using the da Vinci Surgical System to perform surgeries. However, as more surgeries are completed, there has also been an increase in the number of adverse event reports to the U.S. Food and Drug Administration’s Manufacturer and User Facility Experience database.

According to Intuitive Surgical, from 2011 to 2012 there was a 26 percent increase in the number of procedures done with the da Vinci robotic surgical system. During this same time, according to the FDA’s database, there was a 34 percent increase in the number of adverse event reports, such as accidental burns, punctures and other injuries, including death.

In recent months, the company even sent out an “urgent medical device notification” warning that certain versions of the cautery scissors used with the surgical system may develop very small cracks that could leak electrical energy and burn tissue. These micro cracks are small enough that the user may not even notice them. However, the damage can still be quite significant.

In releasing this warning, when weighing a recall verses public need, the company said the risks associated with pulling the product was higher than the risks associated with having to postpone and reschedule time sensitive surgeries. This logic is why a warning was sent out instead of a recall.

Looking to the future, it will be interesting to see if these crack-prone scissors lead to an even higher increase in the number of lawsuits filed against Intuitive Surgical. Already, the company is named in more than 25 product liability lawsuits related to either defective equipment or inadequate training that led to patient injury or death.

Source: Medscape, “Crack-Prone Scissors May Burn Patients, Da Vinci Maker Says,” Robert Lowes, May 13, 2013



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