Functional device failure without injury or harm

**Definition:** A device not working or operating correctly, or that has stopped functioning after a period of function, but without documented injury or harm to the patient.

**Exclusions:** - Retained intrauterine device without injury or harm in non-pregnant uterus - Retained intrauterine contraceptive device in pregnancy - Breakage of device without documented injury or harm - Functional device failure, as mode of injury or harm