Robotic Urologic Surgery: Trends in Food and Drug Administration-Reported Adverse Events Over the Last Decade.

Farnoosh Nik-Ahd, Colby P Souders, Justin Houman, Hanson Zhao, Bilal Chughtai, Jennifer T Anger
Author Information
  1. Farnoosh Nik-Ahd: 1David Geffen School of Medicine, UCLA, Los Angeles, California.
  2. Colby P Souders: 2Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
  3. Justin Houman: 2Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
  4. Hanson Zhao: 2Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
  5. Bilal Chughtai: 3Department of Urology, Weill Cornell Medical Center, New York, New York.
  6. Jennifer T Anger: 2Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.

Abstract

The da Vinci Surgical System has led to a rapid growth in the volume of robot-assisted surgeries, with 877,000 surgeries performed in 2017. Despite the increasing prevalence of robotic urologic surgeries, few long-term studies exist that examine trends in reported adverse events (RAEs). We analyzed RAEs over the past decade. We extrapolated all entries from the Manufacturer and User Facility Device Experience (MAUDE) database with the manufacturer "Intuitive Surgical" from 2007 to 2017. Reports were analyzed for date and type of RAE (death, bodily injury, malfunction, and other). RAEs from urologic surgeries were analyzed further for specific information pertaining to death, bodily injury, and malfunction. A total of 19,783 RAEs were analyzed. Instrument or robot malfunctions comprised the majority of RAEs (84.9%); bodily injuries comprised 8.2%. Death was the least common RAE (1.3%). RAEs for urologic robotic surgeries peaked in 2013 and 2014 and decreased since. A total of 69 (2.3%) deaths, 364 (12.2%) injuries, and 2544 (85.5%) instrument or robot malfunctions occurred. No reported deaths were attributed to system or mechanical malfunction, but rather to medical complications reported to be unrelated to surgery. The most common injuries were bowel (22.3%) and genitourinary (GU) (19.5%). Instrument malfunctions caused 16.8% of bodily injuries. RAEs for robotic urologic surgeries peaked in 2013 to 2014, and have decreased annually since. When malfunctions occurred, they did not result in death and infrequently resulted in bodily injury. Potential quality improvement targets include prevention of bowel and GU injuries through surgical coaching, and improved technology to prevent malfunction of the surgical system and instruments.

Keywords

MeSH Term

Cystectomy
Databases, Factual
Equipment Failure
Foreign Bodies
Genitalia
Humans
Intestines
Intraoperative Complications
Nephrectomy
Postoperative Complications
Prostatectomy
Robotic Surgical Procedures
United States
United States Food and Drug Administration
Urinary Tract
Urologic Surgical Procedures
Urology
Vascular System Injuries

Word Cloud

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