VA, FDA, CDC Release Joint Endoscope-Processing Notice

Adverse Event Reporting for Healthcare Facilities

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect a reportable adverse event associated with endoscopes and endoscope processing, you should follow the reporting procedure established by your facility. Prompt reporting of adverse events can improve FDA’s understanding of and ability to communicate the risks associated with devices, and assist in the identification of potential future problems associated with medical devices.

We also encourage you to report any medical device adverse events related to endoscopes and endoscope processing that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer or to MedWatch, the FDA’s voluntary reporting program. This can be done on-line by filing a voluntary report, by phone at 1-800-FDA-1088, or obtain the fillable form online, print it and fax to 1-800-FDA-0178 or mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.