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

  • Colby Souders
  • Farnoosh Nik-Ahd
  • Hanson Zhao
  • Karyn Eilber
  • Bilal Chugtai
  • Jennifer AngerEmail author
Original Article
  • 23 Downloads

Abstract

Introduction and hypothesis

As surgeons increase the volume of robotic abdominal sacrocolpopexies (rASCs) and become more experienced, a subsequent decrease in the number of adverse events is expected over time. Further, as the leading manufacturer of the operative robot (Intuitive Surgical) improves the technology, adverse events should also decrease. We hypothesized that there has been a decrease in adverse event reporting for rASCs and that serious adverse events are rare.

Methods

We performed a search of the FDA Manufacturer and User Facility Device Experience (MAUDE) database. All entries with the manufacturer “Intuitive Surgical” were exported from 2007 to 2017. All entries with “sacrocolpopexy” were then isolated and analyzed.

Results

The number of adverse events reported for rASC peaked in 2013 and 2014, at 107 and 124 respectively. In 2015 and 2016, the number dropped to 11 and 7 respectively. There were 334 reported adverse events from 2007 to 2017. Five (1.50%) were categorized as death, 33 (9.88%) as injury, and 296 (88.62%) as malfunction. Analysis of the malfunction reports found that 15 out of 296 (5.07%) were converted to open surgery, 4 out of 296 (1.3%) were converted to laparoscopic surgery, 4 out of 296 (1.3%) cases were aborted, and 6 out of 296 (2.03%) malfunctions resulted in patient injury.

Conclusions

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.

Keywords

Abdominal sacrocolpopexy Adverse events Pelvic organ prolapse Robotic surgery 

Abbreviations

rASC

Robotic abdominal sacrocolpopexy

MAUDE

Manufacturer and user facility device experience

POP

Pelvic organ prolapse

RAEs

Reported adverse events

Notes

Compliance with ethical standards

Conflicts of interest

None.

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Copyright information

© The International Urogynecological Association 2019

Authors and Affiliations

  1. 1.Cedars-Sinai Medical CenterBeverly HillsUSA
  2. 2.David Geffen School of Medicine at University of California Los AngelesLos AngelesUSA
  3. 3.Weill Cornell Medical CenterNew YorkUSA

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