The device in this report has not been returned to olympus medical systems corp.(omsc), therefore omsc could not confirm the device.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.The exact cause of the reported event could not be conclusively determined.Omsc surmised that the user reprocessing of the device was inappropriate.If significant additional information is received, this report will be supplemented.
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Olympus was informed by the user facility that the device was not reprocessed according to the instruction manual.During the reprocessing, the user washed the device's outer surface with household detergent and immersed the device with sterihide.However, the user skipped the device brushing at that time.There is a possibility of insufficient cleaning because the device was not brushed.There was no report of patient injury associated with this event.
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