The lot complaint history was reviewed, this is the second complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.Inspection of the probe found the pneumatic open drive line occluded with adhesive which would prevent actuation of the probe cutter.The occlusion of the open drive line will render the device inoperable (i.E.Unable to cut).The root cause is consistent with a manufacturing error where the driveline likely became occluded during the wetting of the pneumatic tubing with solvent and subsequent insertion to the probe engine.In order to mitigate the occurrence of this type of event, during the manufacturing process, downstream in-process checks after final assembly are utilized to help screen out this type of defect from occurring.An action was opened to determine a root cause and implement appropriate corrective actions for complaints of a similar nature.Manufacturing has isolated and identified the major contributor to be the curing process that occurs during the bonding phase of the tubing to the probe pneumatic ports.Corrective actions have been implemented to optimize the probe assembly process.The manufacturer internal reference number is:(b)(4).
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