Medical Device Safety and Recalls: Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Olympus Validates Updated Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication

Olympus Corporation of the Americas (Olympus) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160VF duodenoscope models (160 F/VF duodenoscope models) to replace those provided in the original device labeling. The FDA reviewed the updated reprocessing instructions and the validation data and determined that they meet the Agency's expectations. We recommend that facilities using Olympus' 160 F/VF duodenoscope models train staff on the updated instructions and implement them as soon as possible.

For more information, please see: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm490395.htm

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