Problems With Robotic Surgery Underreported
16September2013
Complications from surgery involving robotic devices may occur more often than many patients realize, according to a new study by researchers at Johns Hopkins School of Medicine.
While robot-assisted surgery is increasingly common, the study in the Journal of Healthcare Quality indicates that a haphazard system of reporting complications gives a misleading impression of the safety of the robotic surgery.
The Johns Hopkins medical researchers noted that doctors have performed more than one million robotic surgeries since 2000, but only 145 surgical complications, including 71 patient deaths, have been reported to the Food and Drug Administration (FDA).
Dr. Martin Makary, Associate Professor of Surgery at Johns Hopkins, said doctors and patients cannot make a proper evaluation of the safety of medical equipment when the system of collecting data is haphazard and not transparent.
When a medical device malfunctions, hospitals are required to report the malfunction to the manufacturer, which is in turn required to report problems to the FDA. But that is not occurring, the researchers contend.
Makary and his fellow researchers reviewed reports to the FDA database of adverse events from Jan. 1, 2000 to Aug. 1, 2012. They also searched for adverse events in news accounts in LexisNexis and in court filings in Pacer. They found eight cases that were not properly reported to the FDA, including five that were never reported at all. Makary said it is probable that many other incidents simply went unreported.
The types of robot-assisted surgical procedures most commonly associated with patient deaths were gynecologic procedures (22 of the 71 reported deaths), urologic (15 deaths), and cardiothoracic (12 deaths). Excessive bleeding was the most frequently cited cause of death.
A more systematic error reporting system and more accurate information are needed to ensure that patients are fully aware of potential risks of robot assisted procedures, the researchers said.
The Seattle medical malpractice lawyers at Morrow Kidman Tinker Macey-Cushman, PLLC represent victims of medical negligence in Seattle and across Washington.
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