The observed failure appears to be consistent with an overlarge down or lateral application of mechanical stress to the tube at or near the external collar of the port housing.While it is impossible to know how the mechanical stress was exerted onto the access port, we do know that variations in port placement can be an issue.The instructions and illustration of optimal port placement are included in the lap-band systems instructions for use (ifu): failure to create a stable, smooth path for the access port tubing, without sharp turns or bends, can result in tubing breaks and leakage.In order to avoid incorrect placement, the port should be placed lateral to the trocar opening.A pocket must be created for the port so that it is placed far enough from the trocar path to avoid abrupt kinking of the tubing.The tubing path should point in the direction of the access port connector so that the tubing will form a straight line with a gentle arching transition into the abdomen as shown in the diagrams below.No new risks identified, the current risk for this event is with a low rate of occurrence for the reported complaint category.No correction or corrective action required.The lot history record for the port lot and band was reviewed and no discrepencies or non-conformances recorded.Product was manufactured according to specification.Unable to determine root cause.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.
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