The Food and Drug Administration has a special "exemption" for medical device manufacturers that lets them file reports of malfunctions in a database that can't be accessed by doctors or the public, reports HuffPost. Since 2016, there have been 1.1 million incidents that have been filed in an "alternative summary reporting" database, according to Kaiser Health News. While deaths caused by medical devices have to be reported to a public database known as MAUDE, the hidden database has serious injury and malfunction reports for about 100 medical devices. In this video interview from Kaiser Health News, Phil Levering talks about his father, Mark, undergoing surgery for a liver abscess that was initially thought to be cancer.
That relief turned to dread the day of surgery. The procedure was supposed to last two hours, she said. But the surgery hit a snag when the stapler “misfired,” according to the surgeon, causing so much bleeding that the minimally invasive procedure was converted to an open procedure so the doctor could suture the vein.
Levering underwent CPR for 22 minutes. A code blue was called, a nurse testified. Levering lost 3 quarts of blood — about half the blood in his body. He was put on life support and would remain in a coma for weeks.