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Robotic sacrocolpopexy: adverse events reported to the FDA over the last decade.

Colby SoudersFarnoosh Nik-AhdHanson ZhaoKaryn EilberBilal ChugtaiJennifer T Anger
Published in: International urogynecology journal (2019)
Although the MAUDE database has its limitations, it does indicate that the number of adverse events reported for rASC peaked in 2013 and 2014 and has decreased annually since then. This may be due to improved proficiency of the surgeon and surgical team, in addition to improvements in the robot. When malfunctions do occur, they infrequently cause serious injury or have an impact on surgical approach.
Keyphrases
  • robot assisted
  • palliative care
  • minimally invasive
  • quality improvement
  • adverse drug
  • emergency department