The FDA cannot foresee every possible outcome. There are usually a specific set of circumstances under which the device will be used, so if the device can pass certain quality and life-tests, it should not be an issue. However, it is possible for a device to be used outside of the normal mode of usage, or if it was used for a patient it was not originally designed for, resulting in a malfunction. Regardless of whether the patient was or was not instructed to use the device, the complaint must be addressed. If this becomes recurring or causes a fatal error, the device must be recalled even though it passed the previous set of tests. While the manufacturer and the FDA both want to prevent the worst possible outcomes, Murphy’s law comes into play. To avoid this as best as possible, the FDA would have to broaden the scope of possible problems and make the criteria for acceptance more narrow.