The manufacturers of endoscopes linked to superbug outbreaks failed to receive clearance before marketing their devices, failed to issue adequate cleaning instructions and failed to report adverse events.
The U.S. Food and Drug Administration warned manufacturers Olympus, Pentax and Fujifilm of their violations in letters on August 12.
Superbug outbreaks linked to endoscopes made by the manufacturers resulted in infections and deaths in nine outbreaks in the U.S. and one in Europe. Superbugs are antibiotic-resistant bacteria, and infections are incredibly difficult to treat.
According to the letters, the FDA warned Olympus for failing to report a device that may have caused death or serious injury within 30 days and for marketing a device without FDA clearance.
