The subject device was returned to the olympus local service department for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Investigation on microbial detection: nonconformity of the subject device, which may affect the reported event, was not confirmed via device inspection result of the olympus local service department.The exact cause of this event could not be conclusively determined.Investigation of dirt inside the light guide lens: olympus medical systems corp.(omsc) was informed from the olympus local service department that it was found that the subject device has water leaks, the light guide lens scratches, and the light guide lens repair adhesive wear.The exact cause of this event could not be conclusively determined.Omsc surmised that the reported phenomenon occurred due to the following causes.- the gap occurred at the light guide lens adhesive due to influence of physical stress and dirt might enter the light guide lens from the gap.- the moisture entered the subject device and components inside the light guide lens got corroded and the corrosion product may have remained under the light guide lens as dirt.
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Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from the subject device tested positive for unspecified microbes.Other detailed information such as the reprocessing method was not provided.There was no report of infection associated with this report.Olympus medical systems corp.(omsc) was informed that during the incoming inspection for repair at the olympus local service department, it was found that inside of the light guide lens of the subject device was dirty.Other detailed information was not provided.There was no reported of patient injury associated with the event.The dates of the two events were unknown.
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