The serial number was not provided.The subject device has not been returned to olympus for evaluation.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.Please see the following patient identifiers for related complaints: (b)(6) ,(model number: maj-2110), (b)(6) ,(model number: maj-2111) ,(b)(6) ,(model number: maj-2113) ,(b)(6), (model number: maj-2112) (b)(6),(model number: oer-elite) ,(b)(6), (model number: maj-2110), (b)(6),(model number: maj-2110) , (b)(6),(model number: maj-2110), (b)(6), (model number: maj-2110) ,(b)(6),(model number: maj-2111), (b)(6), (model number: maj-2112), (b)(6),(model number: maj-2112), (b)(6),(model number: maj-2113) ,(b)(6),(model number: maj-2113).The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned for evaluation.However, based on the results of the investigation, it¿s likely the connector of connecting tube was unable to be connected as external stress was applied to the tube, which broke the connector.It¿s probable the root cause of the external stress is due to the user applying force in an incorrect direction.The final root cause of this 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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