Olympus recalls duodenoscope model for safety modification

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Olympus has recalled its TJF-Q180V duodenoscope so it can make Food and Drug Administration-approved modifications to the roughly 4,400 devices in use in U.S. health care facilities, the FDA announced today. Olympus plans to contact each facility that owns the duodenoscope with instructions on returning the model so it can replace the elevator channel sealing mechanism at the tip of the scope with a new sealing mechanism designed to reduce the risk of fluid leakage into the elevator channel. Olympus estimates a four-day turnaround time once it receives a duodenoscope from a facility. Until then, health care facilities may continue to use the model but‎ should meticulously follow the new, validated reprocessing instructions announced by FDA last March, the agency said. The company also plans to conduct annual inspections of each scope in use by facilities to identify any wear and tear on the sealing mechanism or the presence of attached debris at the scope’s tip, which would require replacement of the potentially contaminated parts.

Topic: Quality and Patient Safety
Tags: quality, patient safety

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