COMPANY FAILED TO ALERT FDA OF DEVICE MALFUNCTIONS
FDA investigators found that Apple Medical's procedures regarding its gynecologic electrocautery devices violated several current good manufacturing practice regulations, the agency said in a warning letter.
Apple's director of operations responded to the agency's Form 483, but only a few of his responses were adequate, said the letter, posted Jan. 4 to the FDA website.
Apple Medical's complaint reporting and medical device reporting processes for the Fischer Cone Biopsy Excisor (FCBE) were flawed, according to the April 25 warning letter. Reviews of 62 complaints lacked required information and forms. For example, some of the reviews did not explain why the company did not investigate the complaints, the letter said.
Further, Apple's "decision tree" did not help the company determine whether a complaint should be reported, and some adverse events went unreported, such as the melting of FCBEs. At a minimum, the company should have reported the melting as a malfunction, since it was likely to cause serious injury, the agency said.