The customer's allegation was confirmed.The device evaluation found the lock levers on the reprocessor side connector were broken.Based on the results of the investigation, it is likely that the following led to the malfunction: external stress, such as user applied force in an incorrect direction, was applied to lock levers of the connecting tube, which broke the lever and the tube was unable to be connected.However, a definitive root cause cannot be identified.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.This issue is addressed in the instructions for use (ifu): "preparation and inspection: visually inspect the connecting tube to ensure that there are no cracks, breaks, rips, scratches, attached debris, or other irregularities.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 the field performance of this device.Should additional relevant information become available, a supplemental report will be submitted.
|