Reporting Surgical Fires to FDA
Health Care Professionals and Consumers:
We encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. In addition to being a repository for safety reports, MedWatch is also a source for timely safety information to consumers and healthcare professionals.
FDA analyzes the information reported to MedWatch, may conduct further investigations and/or institute corrective actions as warranted, and provides information to the public.
If you experience a surgical fire, report the event to MedWatch.
To help us learn as much as possible about the event, please include the following in your reports, if available:
- Make and model of devices thought to be ignition sources (e.g. electrosurgical units, lasers, fiberoptic cables, etc.).
- Make and model of devices or drugs that were fuel sources (e.g. drapes, antiseptic skin preparation agents)
- Whether or not supplemental oxygen was used, and at what concentration (e.g. 100%)
- What delivery system was used to deliver the supplemental oxygen (e.g. endotracheal tube)
- Any additional identifying information including catalog and serial number
- A complete description of the event including patient outcome
- The health care provider's description of the event and their thoughts on how the device contributed to the event
- Device design or labeling that may have contributed to the event
- Whether or not the device(s) have been evaluated, including the evaluation results, if available.