The complaint device was returned to stryker sustainability solutions for evaluation.The results of the visual and functional testing performed determined that the reported event was not confirmed.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: clamping and / or activating the device without having tissue between the jaw assembly.Tissue accumulation between the blade and shaft.Improper usage and inadequate cleaning of instrument.Ancillary equipment (handpiece / generator).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 reported event will continue to be monitored through post-market surveillance.
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