BACKGROUND: Since its Food and Drug Administration (FDA) approval, robot-assisted laparoscopic surgery has grown with expanding indications. One factor used to expand indications is device-related complications. We designed a study to evaluate device-related robotic surgery complications reported to FDA.
METHODS: We searched the FDA device-related complication database, LexisNexis, and PACER (Public Access to Court Electronic Records) to identify robotic surgery-related complications over a 12-year period (January 1, 2000 to August 1, 2012). Cases from LexisNexis and PACER were cross-referenced with the FDA database to determine cases where an FDA report was inaccurate, filed late or not filed.
RESULTS: A total of 245 events were reported to the FDA during the study period, including 71 deaths and 174 nonfatal injuries. Median time to report an event to the FDA was 30 days (range = 0-930 days). Eight cases were identified from the LexisNexis and PACER searches where FDA reports were improperly filed. In five of these, no report was filed with a mean follow-up of 4.1 years (range = 2.3-5.8 years). In the three cases where a report was filed, the mean time between the event and the FDA report was 20.4 months (611 days, range = 292-930 days).
CONCLUSIONS: It is important that the true incidence of complications with robotic-assisted laparoscopic surgery be known to ensure continued safe innovation.
}, year = {2015}, journal = {J Healthc Qual}, volume = {37}, pages = {133-8}, month = {12/2015}, issn = {1945-1474}, doi = {10.1111/jhq.12036}, language = {eng}, }