What should be done if a serious injury caused by a medical device is not known to the manufacturer?

If a serious injury caused by a medical device is not known to the manufacturer, it is crucial to report the incident to the FDA within 10 days. The FDA requires manufacturers, and other parties such as device users or health professionals, to report any serious adverse events or injuries related to medical devices. This immediate reporting helps ensure that the agency can monitor the safety and effectiveness of devices in the market, potentially leading to necessary interventions, product recalls, or updates to safety information.

Timely reporting also allows the FDA to conduct thorough investigations, assess the risk associated with specific devices, and take appropriate actions to protect public health. This obligation underscores the importance of vigilance and accountability in medical device usage and illustrates how the healthcare system collaborates with regulatory bodies to ensure patient safety.

While other options may involve actions that could also be necessary in different contexts, they do not fulfill the immediate requirement to inform the FDA about serious injuries related to medical devices.