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Surgical Robot Troubles Underreported to the FDA

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Jarod Cassidy4 years ago

According to PBS, research has found that some problems and deaths linked to da Vinci Surgical Robotic Surgical System malfunctions have been reported inaccurately, late, or, in some cases, not reported at all.

Recent Concerns with the da Vinci Surgical Robot

  • The da Vinci Surgical Robot was designed by Intuitive Surgical to complete surgeries using a minimally invasive approach in an attempt to reduce recovery time and post-operation pain.
  • Since 2010, the number of robot assisted surgeries being performed in the U.S. has increased by 60 percent; however, according to Bloomberg, the number of adverse events linked to robot assisted recorded in 2013 are currently double those recorded in 2012 with 3,697 adverse reports being filed through November 3.
  • While the sharp increase in the number of adverse events being reported is alarming in itself, such a disproportionate increase in the number of adverse events relative to the number of surgeries performed (100 percent to 60 percent respectively) also suggests the likelihood that numerous adverse events simply went unreported in previous years.
  • Evidence of underreporting was recorded in a recent study in which researchers attempted to analyze the number of device malfunctions being reported in connection to the da Vinci Robotic Surgical System.

About the Latest da Vinci Surgical Robot Study

  • When a medical device malfunctions, the hospital at which the malfunction occurred is required to report the incident to the device’s manufacturer.
  • The manufacturer then reports the malfunction to the FDA, after which the FDA enters the incident into its Manufacturer and User Facility Device Experience database.
  • In the study published in the Journal for Healthcare Quality, researchers sorted through multiple of databases and looked specifically for reports of equipment problems linked to the da Vinci Robotic Surgical System.
  • The researchers found 245 of these incidents that were recorded in the FDA’s Manufacturer and User Facility Device Experience database. 71 of these incidents resulted in death and the other 174 had led to nonfatal injuries.
  • However, the researchers also found that eight of these incident reports were filed late or contained in accurate information and discovered an addition five incidents had never been reported to the FDA at all.
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