Colby Souders1, Farnoosh Nik-Ahd2, Hanson Zhao1, Karyn Eilber1, Bilal Chugtai3, Jennifer Anger4. 1. Cedars-Sinai Medical Center, 99 N. La Cienega Blvd., Suite M102, Beverly Hills, CA, 90211, USA. 2. David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA. 3. Weill Cornell Medical Center, New York, USA. 4. Cedars-Sinai Medical Center, 99 N. La Cienega Blvd., Suite M102, Beverly Hills, CA, 90211, USA. janger@cshs.org.
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.
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 patientinjury. 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.
Entities:
Keywords:
Abdominal sacrocolpopexy; Adverse events; Pelvic organ prolapse; Robotic surgery
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