U.S. Fatal and Serious Injuries from the da Vinci Robot Grew 34% Last Year
Continued from Part 1. The da Vinci robot is touted as the only multi-purpose robot of its type. The Houston surgical injury attorneys at Denena Points, PC understand that it has been used for prostate removal, heart bypass, heart valve repair, and hysterectomy surgeries. The robot’s computerized technology allows a surgeon to manipulate the laparoscopic surgical instruments attached to the robot’s arms while viewing the procedure in 3 dimensions.
The FDA noticed a 34% rise in the number of adverse event reports in its MAUDE (Manufacturer And User facility Device Experience) database related to use of the robot from 2011 to 2012. During the same time period, the actual number of procedures using the robot grew by only 26%.
A study by researchers from Johns Hopkins University examining the problem of the underreporting of injuries caused by the da Vinci robot was published on August 27, 2012 by the Journal for Healthcare Equality. The study covered 12 years of complications related to use of the robot. Researchers cross-referenced the reports in the FDA’s MAUDE database with reports they found in LexisNexus and public court records. Our Houston surgical injury attorneys point out that the researchers found that 245 incidents were reported that included 71 deaths and 174 nonfatal injuries. They found an additional five cases that had never been reported at all and three that were only reported months after the adverse event occurred.
The Houston surgical injury attorneys at Denena Points, PC note that the technique of cross-referencing reports in government databases with reports found in court records, news media stories, and LexisNexis is also used by those who want to study the incidence of amusement ride injuries and fatalities, another area where reporting is largely voluntary and haphazard at best.
Technically, medical device manufacturers are required to report serious injuries and deaths from their products to the FDA within 30 days. But where the manufacturer does not receive any report from a hospital or medical facility, which might want to minimize adverse events and sweep them under the rug if they can, the medical device maker has nothing to report. Hospitals are required to report medical device malfunctions to the manufacturers, but this doesn’t always happen.
When the FDA does receive an adverse event report, it puts the data in the MAUDE database. The FDA can issue warning letters to manufacturers who fail to report adverse events as required. And the agency can also exercise enforcement and compliance options, including issuing injunctions and seizing products. (But our Houston surgical injury attorneys remark that it’s rather difficult to know that the device maker failed in its obligations if the FDA never hears about adverse events.)
Dr. Martin A. Makary, an associate professor of surgery at Johns Hopkins and lead author of the report in the Journal for Healthcare Equality about deficiencies in da Vinci robot adverse event reporting, noted that the FDA’s reporting mandate lacks teeth. “In health care, one fifth of the economy,” there’s a “haphazard smattering” of reports that rely on “voluntary self-reporting with no oversight, no enforcement, and no consequences.” Dr. Makary also mentioned that a 2010 study had found that 56.8% (well over half) of surgeons surveyed anonymously admitted experiencing irrecoverable operative malfunctions while using the robot. (Source: New York Times Blogs, 9/9/13)
The Houston surgical injury attorneys at Denena Points, PC caution that complete and accurate adverse event reporting is necessary if patients and surgeons are to make informed choices about appropriate healthcare options in individual cases. Timely and accurate reports are also necessary to ensure that the FDA is alerted to defective medical devices and pulls them from the market as soon as possible, before they cause further injuries or deaths. Click the link to learn more about the widespread problem of medical device injury and fatality underreporting in the U.S. healthcare industry.