Several lawsuits have been filed around the country on behalf of patients who allege injury from surgery with the da Vinci surgical robot manufactured and distributed by Intuitive Surgical, Inc., a California company.
The personal injury and wrongful death lawsuits allege that the da Vinci Robot is defective, the instruction manual was vague and the company did not adequately train surgeons to use the device. Many of the lawsuits involve thermal burn injuries during hysterectomies and prostatectomies. Some of the lawsuits claim a machine malfunction.
During an inspection of Intuitive Surgical, the U.S. Food and Drug Administration (FDA) found that the company failed to report 4 corrective actions taken to reduce the risk to health posted by the di Vinci Surgical Robot and failed to tell the FDA of reports of thermal burn injuries from the device:
- On 10/10/2011, Intuitive sent out a letter to da Vinci clients (surgeons and hospitals) with suggestions and recommendations for the proper use of instruments with tip covers and for the correct generators that should be used with monopolar instruments. This correction was in response to complaints that arcing through damaged tip covers had caused patient injury. Between January 2010 and December 2011, Intuitive Surgical received 134 complaints of injuries related to tip cover issues.
- On 10/13/2011, the company sent out a letter notifying da Vinci clients that the da Vinci surgical systems are not cleared for thyroidectomies. Between July 2001 and October 2011, the company received 13 complaints related to thyroid surgeries performed with the da Vinci system.
- On 10/17/2011, the company sent out a letter to da Vinci clients with information for inspection instrument cannulas, proper flushing of instruments and the proper transportation of the da Vinci between buildings. Between January 2010 and September 2011, the company received 19 complaints of patient injury, again from stray electrical currents causing internal burns.
- On 01/24/2013, the company sent out a letter and a user manual addendum for transoral surgery to hospitals and clinics. The letter clarified the types of patients and conditions for which daVinci transoral surgery is indicated. For example, the new version of the manual warns that da Vinci transoral surgery is not indicated for pediatric patients. The FDA stated in its report that the vagueness in the previous version of the user manual represented a health risk to pediatric patients.
Attorney Fred Pritzker represents clients in product liability and medical malpractice lawsuits against medical device companies, hospitals and doctors.