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.

User Facilities:
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