Device was not returned for evaluation and could not be evaluated.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be that olympus was unable to resolve the user¿s concerns.Therefore, the user possibly conducted reprocessing with incorrect steps.The event can be detected/prevented by following the instructions for use (ifu) which state: chapter 6 reprocessing operations 6.2 precleaning, leak testing, and manual cleaning endoscopes must be first cleaned according to one of two ways, prior to reprocessing in the oer-elite: ¿ precleaning and manual cleaning immediately after each patient examination, perform bedside precleaning, clean the outer surfaces of the endoscope, brush the suction channel, flush and rinse all channels according to the step-by-step cleaning procedure described in the endoscope¿s reprocessing manual.Complete both the prescribed bedside and manual cleaning procedures.After the endoscope undergoes full manual cleaning, it can be reprocessed in the oer-elite.The oer-elite then provides supplemental cleaning and high-level disinfection.Modified precleaning and manual cleaning immediately after each patient examination, perform the bedside-precleaning and manual-cleaning procedures for the endoscope as described in the endoscope¿s reprocessing manual, but with the modifications described in this section.This section describes: 1) how certain steps performed at the bedside can be performed using less fluid volume, and using water in place of detergent, 2) how the manual steps for brushing the channels and the elevator (if applicable), and for cleaning the outside surfaces of the endoscope are unchanged, and 3) how the requirement to connect certain flushing tubes, and the need to manually flush detergent and rinse water through the channels can be omitted.The functions of the modified/omitted steps are covered by the cleaning process of the oer-elite.After cleaning the endoscope following this modified procedure, the endoscope can be placed in the oer-elite.The oer-elite completes the cleaning process and follows this with high-level disinfection.Olympus will continue to monitor field performance for this device.
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