The complaint device was returned to (b)(4) for evaluation.During visual inspection, the distal gasket on the rod was examined and revealed signs of damage and wearing of the gasket lip which would allow fluid/tissue to rise up the rod.The device did not operate as a result of a build up of fluid/tissue along the distal end of the inner rod.A review of the device history record indicates the device met all inspection and test criteria prior to release.The potential root cause is damage to the distal gasket subsequent to distribution at customer site (e.G.Tissue impaction through use).The instructions for use (ifu) states: "for optimal performance and to avoid tissue sticking, clean the instrument blade, clamp arm, and distal end of the shaft throughout the procedure by activating the instrument tip in saline.".
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