Parker Waichman LLP

Two Intuitive Surgical da Vinci Robot Recalls Receive FDA Class Designations

Two recent actions involving more than 110,000 components of Intuitive Surgical’s da Vinci surgical robot system have been deemed Class II recalls by the U.S. Food and Drug Administration (FDA). The FDA’s Class II designation involves situations in which “use of or exposure to a violative product may cause temporary or medically reversible adverse health […]

fda-intuitive-surgical-recallsTwo recent actions involving more than 110,000 components of Intuitive Surgical’s da Vinci surgical robot system have been deemed Class II recalls by the U.S. Food and Drug Administration (FDA).

The FDA’s Class II designation involves situations in which “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.”

On November 15th, Intuitive notified customers that a component in the da Vinci’s Endowrist instrument could detach, MassDevice.com reports. The company said the problem affects devices made before October 2011 and involves the jaw insert in the da Vinci’s large needle drivers and mega needle, according to a company press release.

A surgeon should notice if the component detached during surgery, Intuitive’s statement indicated; however, Intuitive’s senior vice president of scientific affairs, David Rosa, told MassDevice.com that at least one event involving this defect resulted in a patient having to undergo a second surgery to remove a piece of the da Vinci. About 1,000 products were affected, Rosa noted.

The second recent Class II designation for the da Vinci system was announced on December 3rd following a November 11, 2013 “Urgent Medical Device Recall” letter issued by Intuitive. The matter involved an instrument arm that could stall during procedures, according to both Intuitive Surgical and the FDA. That recall involved 1,386 da Vinci device arms, MassDevice.com reported.

These recalls are the latest setbacks for Intuitive, which has experienced a dramatic spike in adverse events reported to the FDA, according to MassDevice.com. Intuitive also faces mounting litigation over alleged injury, complication, and death reports involving its da Vinci robot.

In 2004, approximately 33.3 injury reports per 100,000 procedures were received, according to The Wall Street Journal. The figure rose to 50 reports per 100,000 procedures in 2012 and, of the 282 reports received, 28 involved deaths, up 34 percent from 2011. A draft analysis of adverse event reports co-authored by doctors at Rush University Medical Center, the University of Illinois, and the Massachusetts Institute of Technology, revealed a significant increase in injury and death rates tied to robotic surgery, as well.

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Bravo! We won! Meredith Ippolito and Joonho Hong has been truly wonderful to work with! The team has been on top of my case since the beginning, informing me with every detail and making the entire experience at such ease and worry free. They are extremely professional, attentive and I have been very fortunate to have Meredith Ippolito and Joonho Hong on my case. Thank you Meredith Ippolito and Joonho Hong & Parker Waichman!
Ji Moon
a year ago
5 Star Reviews 150
Positive: Professionalism , Quality , Responsiveness helped my dad win his case was very professional and everything went very smooth and easy.... special shout out to tina morace.
Adam Marcus
2 years ago
5 Star Reviews 150
Thank you Parker Waichman LLP and especially paralegal Benita Rollis who guided me through the whole process. She was very professional, courteous and always called me back when I had any questions. I was very satisfied and highly recommend Parker Waichman LLP.
Denise Saraceno
2 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038