Abstract: The research on medical device adverse events(MDAE) monitoring has become an important aspect of the post-marketing medical device risk management. Use error is a potential risk related to the use of medical devices, it is significant to study. The article analyzed the use error of medical devices and the approach for risk assessment, in order to be helpful to the medical device adverse event monitoring and evaluation.

Key words: medical device, adverse events, use error, risk assessment, hazard, injury