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Da Vinci Surgical Robot Maker May Have Violated FDA Regulations

susan_harr3 years ago

Intuitive Surgical, maker of the da Vinci Surgical Robot System, may have violated federal regulations in sending a letter to hospitals and doctors which provided recommendations for avoiding a dangerous surgical complication linked to the device.

The FDA reportedly sent the company a “483” letter, alleging they failed to inform the administration of their intent to send out letters to doctors and hospitals throughout the nation. The 483 letter gives Intuitive a chance to respond and/or contest observations and findings.

FDA Letter to Intuitive Outlines 4 Inspectional Observations

According to the 483 letter sent to Intuitive by the FDA, a field investigator documented the following observations during inspections at an Intuitive facility from April 1, 2013- May 30, 2013:

  1. A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to the FDA.
  2. Illnesses or injuries that have occurred with use of devices subject to corrections or removals have not been reported.
  3. Procedures for design change have not been adequately established.
  4. Design input requirements were not adequately documented.

FDA Questions the da Vinci Surgical Letter

Observation #1, which has attracted national media attention, references a 2011 letter from Intuitive to da Vinci clients (hospitals and doctors who use the device). The FDA claims that this letter provides recommendations meant to help surgeons avoid a documented device complication known as “arcing.”

Arcing occurs when an electrical current escapes from the the tip of a da Vinci device, injuring a patient during surgery.

According to the FDA, these letters contained instructions/recommendations that could be perceived as the basis for labeling changes- and thus Intuitive should have gone to the FDA for official guidance before sending out the letters.

What is the da Vinci Surgical Robot?

  • The da Vinci is a robotic surgical system.  
  • The device can have 3-4 arms which are manipulated to perform surgery by a doctor using hand controls and a computer console.
  • The system, which has been on the market since 2000, is designed to perform surgery using a minimally invasive approach.
  • The system was used in nearly 400,000 surgeries nationwide in 2012.
DaVinci Surgical Robot Incidents and Injuries

The following incidents and injuries linked to the da Vinci system have been reported. For a full list of possible da Vinci robot surgery side-effects and injuries, click here.

  • From July 2009 to October 2011, Intuitive received 13 complaints related to thyroidectomies performed with the da Vinci system (according to the FDA letter to Intuitive.)
  • Between January 2010 and December 2011, Intuitive received 134 complaints and filed 83 medical device reports related to da Vinci tip cover issues (according to a CNBC news report).
  • Five patient deaths have been linked to da Vinci robot complications (according to an FDA report filed in 2012).
  • The number of da Vinci surgical robot Adverse Event Reports (AERs) increased 34% between 2011 and 2012 (according to the FDA's MAUDE reporting database).
Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.

If you or a loved one was injured during a da Vinci- assisted surgical procedure, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.


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