The device was not returned to stryker sustainability solutions for evaluation.The facility stated that the device will not be released at this time.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr could not be performed as the lot number and serial number were not reported.The reported event could be attributed to the following: ancillary equipment issues (e.G.Handpiece, generator).Tissue accumulation between the blade and shaft and/or blade and jaw assembly.Activation against solid surfaces, repeated use of instrument beyond intended use.Applying pressure between instrument blade and tissue pad without having tissue between them.Prolonged activation.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.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.Should the device become available for return, the investigation will be reopened at that time.
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