The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use and an indention on the teflon pad was identified.The distal gasket was examined and tissue/fluid build up was identified proximal to the distal gasket.The distal gasket appeared to be worn out and showed signs of minimal damage.A review of the dhr supports that the device met all inspection and test criteria prior to release.The most likely root cause of tissue/fluid buildup is damage to the distal gasket.As the causes of distal gasket damage are undetermined at this time; preventative measures have been taken to prevent the escape of any product exhibiting this failure mode.Therefore, the potential root cause is damage to the distal gasket subsequent to distribution at customer site.The instructions for use (ifu) state: "blood and tissue buildup between the blade and shaft may result in abnormally high temperatures at the distal end of the shaft.To prevent burn injury, remove any visible tissue buildup at the distal end of the shaft." "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." "if tissue is still visible in the clamp arm, use hemostats to remove residue, taking care not to actuate the hand piece.If desired, the instrument may be unplugged." "care should be taken not to apply pressure between the instrument blade and tissue pad without having tissue between them.Clamping the tissue pad against the active blade without tissue on the full length of the blade will result in higher blade, clamp arm and distal shaft temperatures and can result in possible damage to the instrument.If this occurs, there may be an instrument failure, and the generator touchscreen displays a troubleshooting message." " the instruments allow for the coagulation of vessels up to and including 5mm in diameter.Do not attempt to seal vessels in excess of 5mm in diameter." "select the desired minimum power level using the increase and decrease buttons on the generator touchscreen.Note: the recommended minimum starting power level is level 3.For greater tissue cutting speed use a higher generator power level, and for greater coagulation use a lower generator power level.The amount of energy delivered to the tissue and resultant tissue effects are a function of many factors, including the power level selected, blade characteristics, grip force, tissue tension, tissue type pathology, and surgical technique." the reported event will continue to be monitored through post-market surveillance.
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