Olympus recalls, redesigns Olympus TJF-Q180V duodenoscope

Editor's Note

The Food and Drug Administration (FDA)  on January 15 cleared the Olympus TJF-Q180V duodenoscope with design and label modifications intended to reduce the risk of bacterial infections.

The new design of the elevator channel sealing mechanism creates a tighter seal and reduces the potential for leakage of fluids and tissue into the channel.

Olympus will contact each facility that owns the original model of the duodenoscope with instructions on returning it so the company can replace the elevator channel sealing mechanism at the tip of the scope.

Olympus also plans to conduct annual inspections of each scope in use by facilities to identify any wear of the elevator channel sealing mechanism or the presence of debris at the scope’s tip, which would require replacement of those parts.

The U.S. Food and Drug Administration today cleared the Olympus TJF-Q180V duodenoscope with modifications to the device's design and labeling intended to help reduce the risk of bacterial infections. Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed repair as quickly as possible.