FDA Surveys Doctors Over Da Vinci Surgery Injuries

da Vinci surgery injuriesDa Vinci surgery injuries have come to be a major concern recently, particularly due to the increasing number of uses of the da Vinci Surgical System in hospitals and facilities across the globe. In early 2013, the U.S. Food and Drug Administration (FDA) conducted a survey to obtain additional information regarding the effectiveness and safety of the robot after reporting a 34 percent increase in adverse event reports between 2011 and 2012 from patients alleging injury and death.

If you or someone you love sustained da Vinci surgery injuries and you would like to learn more about your rights, contact Attorney Group today. You may be entitled to file for compensation and recover damages for your condition.

FDA Conducts Survey Pertaining to Da Vinci Surgery Injuries

The results of the survey conducted by the FDA were released in November 2013 and indicated that, overall, surgeons were pleased with the da Vinci Surgical System as they reported shorter hospital stays and fewer patient complications as benefits of the robot. However, only 11 surgeons responded to the survey, an unfortunately small sample size, and concerns still remain as to whether the use of the da Vinci robot is safe and effective for use on patients.

The survey was administered to six medical providers who were participating in the FDA’s Medical Product Safety Network and five surgeons whom the FDA chose based on referrals from others. Although participants largely reported positive and beneficial experiences with the robot, some reported limited product failings. Many of these complications were mirrored in adverse event reports submitted to the FDA by patients over the last several years.

Reported complications included a drift in the arms of the robot during surgeries, excessive collision of the robotic arms and an electrical arcing in the scissors attached to the device that could lead to internal and unnecessary burns. Surgeons also suggested, according to the survey, that the da Vinci Surgical System may not be appropriate to use in patients currently struggling with obesity.

According to Intuitive Surgical, the manufacturer of the robot, the survey could not be used as a basis for making valid conclusions due to the relatively small sample size. Instead, the manufacturer pointed to larger clinical trials that suggested numerous benefits of robotic-assisted procedures. Still, due to the similarity in claims between surgeons participating in the survey and patients submitting adverse event reports, those filing claims against the manufacturer may find solid evidence and expert witnesses to testify on their behalf in these product liability claims.

Common Reports of Da Vinci Surgery Injuries

Released in 2000, the da Vinci Surgical System is currently used in several medical procedures to treat conditions such as:

  • Kidney cancer
  • Uterine fibroids
  • Throat cancer
  • Endometriosis
  • Intrauterine bleeding
  • Other urological and gynecological conditions

Additionally, the robot is used to perform hysterectomies and to remove the prostate as well as in obesity reduction procedures. Although Intuitive Surgical allegedly promised a faster recovery time for patients, clinical trials and adverse event reports suggest that injuries were not uncommon in patients undergoing treatments with the device. Common complications reported by patients include organ or vessel punctures, uterine lacerations, intestinal tearing, burns and death. Many of those allegedly injured by the da Vinci Surgical System are currently working with attorneys across the U.S. to file claims against Intuitive and recover damages including pain and suffering, medical expenses and lost wages.

Suffering from Da Vinci Surgery Injuries? Attorney Group Can Help

If you or someone you love has undergone a procedure with the da Vinci robot and you are now experiencing adverse or life-threatening injuries, contact Attorney Group to learn more about your legal rights. We will provide you with a free, no-obligation case evaluation and help you to determine if you have a valid claim. Additionally, if you have lost a loved one and you feel the death was attributed to the robot, you may be entitled to file a wrongful death claim on his or her behalf. We will connect you with an affiliated attorney experienced in da Vinci surgery injuries that can handle your case and assist you in filing for the compensation to which you may be entitled.