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.
Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
Device and Drug Manufacturers:
Device manufacturers must comply with the Medical Device Reporting (MDR) regulations. Drug/Biologics Manufacturers, Distributors, and Packers also have mandatory reporting requirements.