Union

Accidental inhalation of a foreign material into the lungs.

Issue associated with any motion of the system or components that was not initiated by the user.

A pregnancy that was not desired or was timed incorrectly at the time that the conception occurred.

Movement of a medical device to an unintended location within the body.

Issue associated with unexpected discharge of device from expected location - includes but not limited to devices such as clip appliers, film…

Issue associated with device or device components impacting with another object.