Surgical or other medical devices, implants or grafts associated with injury or harm in therapeutic use

**Definition:** Medical devices could be associated with injury or harm in therapeutic use through different mechanisms: failure, malfunction, dislodgement, misconnection, removal, unclean/unsterile, use error, inappropriate for related task, poor presentation or packaging, lack of presentation

**Long definition:** A medical device is any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

**Exclusions:** - medical devices associated with adverse incidents due to external causes classified elsewhere