Study: Robotic Surgery Complications Are Underreported

Robotic surgery-related complications are underreported, according to a study by Johns Hopkins researchers published in the Journal for Healthcare Quality.

Researchers used LexisNexis and the Public Access to Court Electronic Records to compare robotic surgery-related errors reported in the news media and court records with reports in the Food and Drug Administration database.

From Jan. 1, 2000, to Aug. 1, 2012, a total of 245 robotic surgery-related complications, including 71 deaths and 174 nonfatal injuries, were reported. The most common cause of death was excessive bleeding, according to a Johns Hopkins news release. Of the 71 deaths, the top three associated procedures were gynecologic with 22 deaths, urologic with 15 deaths and cardiothoracic with 12 deaths. Among nonfatal injuries, the most common procedure was hysterectomy, which accounted for 43 percent of the cases.

Dr. Marty MakaryEight cases of robotic surgery complications were improperly filed, five of which were not reported to the FDA at all, and three of which were reported to the FDA an average of 20.4 months after the event. Two of the reports improperly filed with the FDA were made only after the event appeared in a media outlet, according to the release.

Martin A. Makary, MD, an associate professor of surgery at the Johns Hopkins University School of Medicine in Baltimore and an author of the study, said 245 complications likely represent only a fraction of robotic surgery-related complications that occur. "The number reported is very low for any complex technology used over a million times," he said in the release.

More Articles on Robotic Surgery:

Da Vinci Robots: Minimally Invasive Miracle or Costly Conundrum?
Study: Robotic Surgery Checklist Cuts Readmissions 74%
FDA Investigates Robotic Surgery Effectiveness

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.


IC Database-3

Top 40 Articles from the Past 6 Months