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Research Briefs: Underreporting Robot Surgery Events; AFib, Lung-Cancer Studies

A review of court records and media reports finds several robotic surgery adverse event reports that do not appear in FDA’s public records. DECAAF shows DE-MRI can guide atrial fibrillation ablation. The PanCan study identifies predictors of lung cancer.

A study comparing the adverse event reports collected by FDA with news reports and court records shows that many robotic-surgery related complications are not reported to the agency. Martin Makary of the Johns Hopkins School of Medicine and colleagues searched the FDA device-related complication database, LexisNexis and PACER (Public Access to Court Electronic Records) to find incidents of robotic surgery-related complications from 2000 through July 2012. They cross-referenced cases mentioned in news articles on LexisNexis and court cases in PACER with adverse event reports in the Manufacturer and User Facility Device Experience (MAUDE) to determine if the case was reported accurately to the agency.

Results of the study, published Aug. 27 in the Journal for Healthcare Quality, show that 245 events were reported to...

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