The device was returned and evaluated, and the customer¿s allegation was confirmed.It was found that one side of the gray lock levers and one side of the metal clips were missing, missing gray lock lever and metal clip were not returned for evaluation.In addition, there were stains and scratches noted outside of the tube-connecting tube.Additionally, there were observed scratches, dents/nicks on the metal connector of the connecting tube and nicks/dents on the blue plastic connector.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.H4: based on the lot number the manufacturing date of the device was in the month of august 2012 but a specific date could not be identified.Based on the results of the investigation, it¿s likely the connecting tube could not be connected due to detachment of the lock lever by external stress.As a cause of the external stress, the user may have applied force toward incorrect direction.However, a final root cause of the event was unable to be identified.The event can be detected by following the instructions for use which state: ¿preparation and inspection: move the lock levers of the reprocessor side connector to make sure that they function properly and are not broken.¿ olympus will continue to monitor field performance for this device.
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