Risk acceptance does not necessarily increase the probability that a risk will occur. Risks are typically accepted rather than mitigated when they cannot be further reduced through design changes, when the overall benefits of the device outweigh the potential harms, and when their probability and severity are both low. It’s important to note that for a risk to be accepted, both its probability and severity must fall within the company’s predefined risk acceptance criteria. Risks are often accepted when they are inherent to the device’s intended use, especially when eliminating them would compromise the device’s functionality. A common example of this is orthopedic surgical tools such as saws, drills, and mallets. These instruments inherently carry the possibility that a user could injure themselves or damage unintended tissue on a patient. However, with proper training and technique, the likelihood of these events becomes low. For example, attempting to redesign a surgical saw to fully eliminate the risk of cutting the user would render the device incapable of performing its intended purpose. Risk acceptance ensures devices are effective and functional while acknowledging that some level of inherent risk is unavoidable.