The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The blade, jaw, teflon pad and contact rings appear to be intact.Upon evaluation, the device passed functional testing.A review of the dhr supports that the device met all inspections and test criteria prior to release from stryker.Therefore, the most likely root causes may be attributed to: ancillary equipment issues (e.G.Generator, handpiece, and/or adaptor); generator delivers less energy than displayed settings; improper connection of instrument to hand piece ; user selects improper min settings on generator; tissue accumulation between the blade and shaft.The instructions for use (ifu) state: 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.Incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.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.Note: do not touch the instrument to metal while activated.Note: do not clean the blade tip with abrasives.It can be wiped with a moist gauze sponge to remove tissue, if necessary.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.The reported event will continue to be monitored through post-market surveillance.
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