Robotic sacrocolpopexy: adverse events reported to the FDA over the last decade
- 25 Downloads
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.
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.
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.
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.
KeywordsAbdominal sacrocolpopexy Adverse events Pelvic organ prolapse Robotic surgery
Robotic abdominal sacrocolpopexy
Manufacturer and user facility device experience
Pelvic organ prolapse
Reported adverse events
Compliance with ethical standards
Conflicts of interest
- 7.FDA: US Food and Drug Administration MAUDE. Manufacturer and user facility device experience 2018, 2018. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Accessed May 2018.
- 8.FDA Administration. Mandatory reporting requirements: manufacturers, importers and device user facilities. Internet 2018, 2018. https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/reportingadverseevents/default.htm. Accessed October 2018.