Healthcare professionals and consumers should report serious adverse events or other problems related to surgical staplers and other medical devices through the FDA's MedWatch Program.
The Safe Medical Devices Act of 1990 requires manufacturers, hospitals, and other user facilities to report deaths, serious illness and injuries associated with the use of medical devices.
Questions about mandatory reporting can be answered by the Division of Surveillance Systems, Reporting Systems Monitoring Branch, by phone on 301-827-0360, or write to
Reporting Systems Monitoring Branch
1350 Piccard Drive HFZ-533
Rockville, MD 20850