FDA Investigates Da Vinci Robot Claims

da Vinci robot claimsFollowing a Class II recall released in December 2013, the U.S. Food and Drug Administration (FDA) has recently noted that a second component of the da Vinci Surgical System may cause possible health complications and severe risks. The announcement, made on December 16, 2013, suggests that the EndoWrist instrument of the da Vinci robot has the potential to detach from the unit during procedures. The FDA made the decision to issue a recall for the device as a preventative measure and to call attention to the possibility of injuries or further complications.

FDA Investigates Da Vinci Robot Claims

Regulators had also ordered that the manufacturer, Intuitive Surgical, inspect the Patient Side Manipulator on the da Vinci Surgical System for possible replacement or repair as needed after da Vinci robot claims surfaced regarding potential stalling of the device during procedures. An urgent medical device recall, or a Class II recall, was issued on November 11, 2013 by the FDA.

According to the FDA, a Class II recall involves a situation in which exposure or use of a potentially dangerous product may result in medically-reversible or temporarily adverse health complications or where the possibility of consequences is small.

Between the two most recent recalls, current da Vinci robot claims encompass over 110,000 robotic components. On November 15, 2013, Intuitive reportedly sent a letter to its patients to warn them of the da Vinci robot claims involving the EndoWrist instruments and the potential for the device to cause injury. However, the manufacturer stated that the issue with these components involved da Vinci Surgical Systems made before October 2011 and not necessarily those currently in use today.

The manufacturer also stated on November 19, 2013 that in most cases, it would be difficult or next to impossible for a surgeon not to notice if the EndoWrist instruments detached from the device during procedures. However, one news report focused on a patient who required a second surgery to retrieve and remove a detached component that the surgeon had allegedly missed.

Da Vinci Surgical System Overview

Approved by the FDA in 2000, the da Vinci Surgical System is used to help surgeons in minimally-invasive urologic, laparoscopic and gynecologic surgeries. However, the device has also been recently used in prostatectomies, hysterectomies and thyroid procedures. Over the past several months, the FDA has carefully watched the device as the agency allegedly continues to receive da Vinci robot claims from patients suffering from adverse complications and injuries during surgeries.

In November 2013, the FDA released the results of a study that included several surgeons who had personal experiencing using the system. According to the agency, patients may suffer from bleeding due to perforated bowels, reversible limb palsy and temporary nerve damage in the fingers as well as other severe complications. The FDA is also currently investigating whether allegedly inadequate surgeon training may be a contributing factor in whether a patient experiences adverse or life-threatening complications during procedures.

Patients are filing claims against Intuitive Surgical, alleging that the device causes:

  • Bowel injuries
  • Cut ureters
  • Excessive bleeding
  • Internal burns
  • Death

Additionally, plaintiffs allege that the robotic arm may cut, burn or cauterize otherwise health tissues as the electric current has the potential to jump around from the arm of the device to other areas inside the body. Blood vessels, bowels, bladders, vaginal cuffs, ureters and arteries have all been allegedly affected by the da Vinci robot.

Several plaintiffs have also accused Intuitive of providing misleading information or withholding information altogether pertaining to the potential for the device to cause complications. According to several lawsuits, Intuitive allegedly placed its desire for profit ahead of consumer safety as evident by the company’s stock value; reports indicate that the value of the company soared, despite mounting claims of adverse complications and health risks. Intuitive, for its part, maintains that it did nothing wrong and had no prior knowledge of complications that could arise during procedures.

Concerned about Recent Da Vinci Robot Claims? Contact Us Today

If you or a loved one have sustained injuries or suffered from complications due to the da Vinci Surgical System, contact Attorney Group today to learn more about your rights. We will answer your questions about current da Vinci robot claims to the best of our ability and help you to determine if you have a valid claim. We will connect you with an affiliated attorney who will handle your da Vinci robot claims and help you to seek the compensation to which you may be entitled.