Defective Medical Devices
Pentax Duodenoscope Flaw Linked to Infection Risk
Pentax reported its ED-3490TK duodenoscope had additional design flaws that could lead to patient infection, according to a U.S. Food and Drug Administration Safety Communication. In February 2016, the FDA validated Pextax’s updated duodenoscope cleaning instructions. The instruction update came in response to the FDA’s February 2015 Safety Communication linking…
