According to allegations raised in a medical malpractice and product liability lawsuit filed by an Oregon woman, parts of the da Vinci surgical robot fell off during a robotic surgery and remained undetected for at least seven months.
The complaint was filed late last month in the Multnomah County Circuit Court in Oregon by Heidi Carlson, according to a report by The Oregonian.
Carlson claims that a part of the surgical robot’s arm fell into her abdominal cavity during a procedure in September 2012, and the missing part went unnoticed by health care professionals involved in the robotic surgery. The foreign object was not discovered for seven months, when it was revealed by a CT scan and the piece was removed. During that time, Carlson alleges that she suffered severe and incapacitating pain.
According to the lawsuit, lead surgeon Dr. Philippa Ribbink failed to notice the part was missing or that it was inside of Carlson’s body and failed to order a CT scan, despite months of Carlson’s complaints of agonizing abdominal pain following the surgery.
The lawsuit seeks $475,000 in damages, pursuing claims against Legacy Emanuel Hospital & Health Center, Legacy Health, Everywoman’s Health P.C., and Intuitive Surgical, Inc., which is the manufacturer of the da Vinci Robotic Surgical System.
Surgery “Never” Events
Incidents like what happened to Carlson are known as unintended retention of foreign objects (URFOs) or retained surgical items (RSIs), and most experts consider them “never events,” meaning that there is no excuse for them ever happening.
In traditional procedures, these problems typically occur when a surgeon accidentally leaves a medical tool inside a patient’s body once surgery is complete.
According to an alert issued by The Joint Commission in October 2013, the medical watchdog group suggested that there could be as many as 2,000 such incidents each year in the United States alone.
It is widely acknowledged that steps can be taken by surgeons and medical staff to avoid incidents where surgical tools or foreign objects are left behind after a procedure, by implementing procedures to keep track of all equipment or items used during a procedure. However, the increasing popularity of robotic surgery may change the scope of post-surgical checks.
da Vinci Robot Problems
The da Vinci Surgical System is a remote control robot featuring four arms that are controlled by a surgeon through the use of hand and foot controls while sitting at a console that provides a virtual reality representation of the patient’s internal organs.
In recent years, the surgical robot has been increasingly used at hospitals throughout the U.S., for a number of different urologic, laparoscopic, gynecologic and non-cardiovascular thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures.
The rapid adoption of robotic surgery has raised concerns in recent years about the adequacy of training provided for surgeons and questions about whether the expensive procedure provides sufficient benefits over traditional surgical techniques for many applications.
Although some research has suggested that surgeons may require several hundred cases before they become proficient with da Vinci robotic surgery, Intuitive Surgical has been criticized for aggressively promoting the medical device in a manner that leads to surgeons using the new technique after minimal training.
Intuitive Surgical has also faced dozens of da Vinci robotic surgery lawsuits filed on behalf of individuals who allege that design defects with the complex device have caused them to suffer burns, tears and other internal injuries.