The FDA maintains a database called MAUDE, which stands for Manufacturer and User Facility Device Experience. MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The on-line search feature allows people to search CDRH database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE is updated monthly and the search page reflects the date of the most recent update. MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Source
A research study that analyzed MAUDE reports of instances of robotic surgical system instrument failures between January 2009 and December 2010 categorized failures into five main groups (cautery, shaft, wrist or tool tip, cable, and control housing) based on technical differences in instrument design and function. The MAUDE database contained 528 reports for a total of 565 instrument failures. There were 285 reports of failures of the instrument’s wrist or tool tip, 174 failures involving cautery problems, 76 reports of shaft failures, 29 reports of cable failures, and 7 reports of control housing failures. There were 49 reports regarding multiple failures and 10 reports from which the mode of failure could not be determined.
The researchers concluded that the data showed “that a number of robotic instrument failures occurred in a short period of time. In reality, many instrument failures may go unreported, thus a true failure rate cannot be determined from these data … We recommend institutions incorporate standard failure reporting policies so that the community of robotic surgery companies and surgeons can improve on existing technologies for optimal patient safety and outcomes.”
In another study of all robotic general surgical procedures performed at a tertiary center between 2008 and 2011, there were reports of 10 cases of robotic malfunction during 223 robotic surgical cases (102 endocrine, 83 hepatopancreaticobiliary, 17 upper gastrointestinal, and 21 lower gastrointestinal colorectal procedures). The 10 cases of robotic malfunction involved 4 failures of robotic instruments, 3 failures of the optical system, 2 failures of the robotic arms, and 1 failure of the robotic console. However, none of the 10 failures led to adverse patient consequences or conversion to open procedures. Six of the 223 robotic surgery procedures were converted to open: 3 due to bleeding, 1 due to difficult dissection plane, 1 due to invasion of tumor to surrounding structures, and 1 due to intolerance of pneumoperitoneum due to CO2 retention. There were no reports of mortality associated with robotic surgery and only 2 cases of morbidity.
Robotic surgery is still a relative new procedure that has not been introduced into all geographic areas in the United States. The da Vinci Surgical System is one of the better known and more commonly used robotic surgical systems in the United States. There have been many positive experiences for both surgeons practicing robotic surgery and their patients upon whom robotic surgeries have been performed. However, from the initial available data regarding da Vinci and other robotic surgeries, it appears that robotic surgeries are subject to issues, problems, complications, and adverse events just like other surgery methods, but some of which are unique to robotic surgery.
If you or a loved one suffered a bad outcome as a result of da Vinci surgery or other robotic surgery, you may be entitled to compensation for the injuries and harms that you sustained. It is important that you promptly consult with a local medical malpractice attorney (da Vinci claim attorney or robotic surgery attorney) who may be able to investigate your da Vinci or robotic surgery claim for you and represent you in a da Vinci claim or robotic surgery claim, if appropriate.
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