FDA WARNING_LETTER - Olympus Medical Systems Corporation

The FDA issued a Warning Letter to Olympus Corporation of the Americas on March 9, 2018, for failing to comply with postmarket surveillance requirements under Section 522 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 360l) and 21 CFR Part 822.

On October 5, 2015, FDA ordered Olympus to conduct postmarket surveillance on duodenoscope models JF-140F, PJF-160, TJF-160F, TJF-160VF, and TJF-Q180V due to the risk of infection and death from reprocessing failures. The order required two studies: a Human Factor Study on user material sufficiency for reprocessing, and a Sampling and Culturing Study to assess microbial contamination post-reprocessing and contributing factors.

Olympus failed to commence data collection for the Sampling and Culturing Study within 15 months of the 522 Order, a direct violation of Section 522. As of February 20, 2018, zero of four required sites were enrolled, and no sampling had begun for the study, which required 1,736 samples. Similarly, for the Human Factors Study, approved September 1, 2017, no participants were enrolled as of December 30, 2017