The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.The device was not returned to olympus for evaluation.Therefore, a definitive root cause could not be determined at this time.The contents of the instruction manual warns: -the rotating clip device is not sterilized before shipping.Please wash and sterilize according to the following procedure before the first use.If used without cleaning or sterility, it may lead to infection or tissue inflammation.-if the rotating clip device is not effectively cleaned and sterilized after use, it may lead to infection and tissue inflammation.Also, the rotating clip device generally comes into contact with the mucous membranes during use.Clean and properly sterilize after use to reduce the risk of infection -wash thoroughly before sterilization to remove microorganisms and organic substances that may interfere with the sterilization effect.If cleaning is neglected, sufficient sterility will not be obtained.The device was not returned to olympus for evaluation.
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The customer was contacted for additional information.The customer reported that the patient has not exhibited any signs or symptoms of an infection due to the event (reusable rotating clip was ultrasonically cleaned, but not sterilized, prior to use).No other information was provided.
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