Olympus recalls duodenoscopes, FDA approves new model

Patient Safety Monitor Insider

January 20, 2016

Olympus Corp., the largest seller of duodenoscopes in the U.S. recalled all of its TJF-Q180V model scopes, last week. The move came just one day after a Senate committee report linked Olympus products to 142 antibiotic-resistant infection (ARI) cases.

Duodenoscopes are flexible cameras inserted into a patient’s mouth or digestive tract to diagnose a number of cancers and are used in over 700,000 procedures annually. Recent investigations found a flaw in the scope’s design made it nearly impossible to fully disinfect – exposing patients to ARIs and resulting in 25 outbreaks in four countries over the last three years. Last year, 141 patients in Los Angeles were infected and three died from ARIs attributed to dirty scopes.

Olympus voluntarily issued the recall after the Food and Drug Administration (FDA) cleared the company’s new safety modifications to the existing model. Olympus will replace the elevator channel sealing mechanism at the tip of the scope with a new mechanism that should reduce the risk of fluid leakage in the channel, according to the report.

Olympus will begin replacing the scopes next month. There are approximately 4,400 scopes currently in use and Olympus hopes to have them all replaced or modified by August 2016. Until the scopes are replaced, healthcare facilities may continue using the unmodified TJF-Q180V models, but are urged to meticulously follow the manufacturer’s reprocessing instructions.

Editor’s Note: This article was adapted from Accreditation & Quality Advisor.