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Third, while these studies discuss potential adverse events from reusable cystoscope procedures, we noted that FDA states that the FDA MAUDE database's MDR data are not intended to be used to evaluate rates of adverse events, evaluate a change in event rates over time, or compare adverse event occurrence rates across devices

10.1212/01.WNL.0000048204.89346.30 Neurology 25 BurdickK

The clearance rates indicated above were within the published ranges for these often employed standards (Di 2003, Shou 2005, Lu 2006, Behera 2008)