Warnings from Kaiser Health News
The FDA letter to health care providers came days after an investigative article by Kaiser Health News revealed the FDA has quietly granted device manufactures exemptions allowing them to log instances of injuries by medical devices into a database hidden from doctors and the public. The online publication spent months asking the FDA about this database which contains reports on about 100 medical devices including surgical staplers and internal staples.
Finally, the government agency confirmed the existence of the reporting-exemption program and thousands of never-before-acknowledged instances of device malfunctions and failures. The article outlines patient stories and doctor’s accounts of medical emergencies caused by stapler devices that led to serious life-altering injuries and death.
According to the article, “surgical staplers have a unique ability to help — or harm — patients. The device is designed to cut and seal tissues or vessels quickly, often during minimally invasive surgeries. When it fails to seal a major blood vessel, medical staff can quickly shift into “code blue” mode to rescue a patient from bleeding to death.”