New Jersey Residents Injured during Robot Surgery
Sheena Wilson, 45, suffered a serious injury during robotic surgery for a hysterectomy. Wilson, a mother of two from Parlin, New Jersey, suffered a burn to her rectum and is now on long-term disability and facing additional surgery.
The Intuitive Surgical Inc. system used by her doctor has been linked to other injuries. A review by Bloomberg found that dozens of injuries were unreported for years.
The Food and Drug Administration (FDA), which regulates medical device, is aware that what it calls “adverse events” are under-reported and is working to improve its system. It estimates that only 15% of incidents involving medical devices are reported.
Medical device companies are required to report incidents involving their products, and the database of information is available online. However, these reports are sometimes unclear and incomplete and are not verified by the FDA.
Adverse event in surgeries that involved a robotic device were not necessarily caused by the device itself.
Intuitive’s da Vinci robotic surgery system has been used in 350,000 operations in the US.
Wilson has filed a lawsuit against Intuitive and her surgeon.
Another woman who spent four months in the hospital when a hole was found in her intestine after a hysterectomy with an Intuitive device is also exploring her legal options against the company.
Michael Grasso, of Manahawkin, New Jersey, has filed a complaint against Intuitive, alleging that he suffered nerve damage when doctors tried to use the Intuitive robot to remove his prostate.
In a robotic operation, a surgeon sits at a console a short distance from the patient and looks at a high definition screen showing the surgical site. Foot and hand controls move the surgical instruments, and a 3-D camera shows the view inside the patient.
The Intuitive system gained FDA approval in 2000, based on a trial of operations for gallbladder removal and heartburn.The system is now used for a wider range of operations, including hysterectomies, prostate cancer operations, and heart valve procedures.
Doctors can use the robotic devices after only a short training course and a few supervised operations.
The FDA received 3,697 reports of deaths, injuries, or malfunctions related to robotic surgery during the first 10 months of 2013.