Medscape Medical News
Robert Lowes
Sept 05, 2013
More injuries and deaths are linked to da Vinci robotic surgery than meet the eye, according to a new study published online August 27 in the Journal for Healthcare Quality.
As a result, "we're not learning from our performance," study coauthor Martin Makary, MD, MPH, told Medscape Medical News.
Between January 1, 2000, and August 1, 2012, the US Food and Drug
Administration (FDA) received 245 adverse event (AE) reports related to
the controversial da Vinci robotic surgical system, made by Intuitive
Surgical. Scouring federal court records and media accounts, Dr. Makary
and colleagues found 5 more cases that were never reported. They also
discovered that 3 reported cases were problematic. One was submitted 930
days after the surgery, and another 292 days after. The latter case, as
well as a third dubious one, was submitted to the FDA only after a
media report of the patient's death appeared.
Read the full Medscape report
