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07.01.2019 | Original Article

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

verfasst von: Colby Souders, Farnoosh Nik-Ahd, Hanson Zhao, Karyn Eilber, Bilal Chugtai, Jennifer Anger

Erschienen in: International Urogynecology Journal

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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.
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Metadaten
Titel
Robotic sacrocolpopexy: adverse events reported to the FDA over the last decade
verfasst von
Colby Souders
Farnoosh Nik-Ahd
Hanson Zhao
Karyn Eilber
Bilal Chugtai
Jennifer Anger
Publikationsdatum
07.01.2019
Verlag
Springer International Publishing
Erschienen in
International Urogynecology Journal
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-018-3845-6

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