Olympus Corp. is defending the quality of its duodenoscopes, which have been linked to several infection outbreaks in the U.S. and Europe since 2010.
"The evidence does not support claims that the infections were caused by Olympus product designs or instructions for use," a statement from the company said.
Olympus says its scopes are safe and effective when properly used, maintained and reprocessed according to their respective instructions for use.
"We regard the security and safety of patients and healthcare professionals as our top priority and will continue to develop safe and secure medical devices in cooperation with healthcare professionals," the statement said.
The company is setting aside more than $85 million to cover losses expected to stem from a federal investigation into its scopes. It is also facing civil lawsuits in the U.S. related to the scopes.