This supplemental report is being submitted to provide the endoscopy support specialist (ess) findings and to update the following sections.The olympus ess visited the user facility on (b)(6) 2017 and observed the following reprocessing deviations: the reprocessing containers are not being cleaned after each use.The water tube was not replaced after each procedure and is being used throughout the day.The user facility does not have a suction machine in the reprocessing room and utilizes a syringe to aspirate the scope channels.After reprocessing, the scopes are laid down instead of being hung in a cabinet as stated in the reprocessing manual.After observing the user facility¿s reprocessing practice, a reprocessing training was provided and the deviations have been addressed and corrected with the user facility staff.In addition, the scope was cultured at the user facility and the scope culture tested negative for growth.Based on the ess findings, the cause of the reported event is likely attributed to insufficient maintenance of the device.The reprocessing manual states, ¿all channels of the endoscope must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.If the endoscope is not cleaned meticulously, effective disinfection or sterilization may not be possible.Clean the endoscope and accessories thoroughly before disinfection or sterilization to remove microorganisms and organic material that could reduce the efficacy of disinfection or sterilization.Hang the endoscope in the storage cabinet with the distal end hanging freely.Make sure that the insertion tube hangs vertically and as straight as possible.The storage cabinet must be clean, dry, well ventilated, and maintained at ambient temperature.Do not store in humidity, or exposed to x-rays and/or ultraviolet-rays.Doing so could damage the endoscope or present an infection control risk.¿.
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