The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, the device revealed evidence of clinical use/activation on the distal tip and a large indentation in the black pad.The teflon pad was melted/detached from the jaw.A review of the dhr supports that the device met all inspection and test criteria prior to release from stryker.Therefore, the most likely root causes are: applying pressure between instrument blade and tissue pad without having tissue between them.Prolonged activation (in general or against solid surfaces).Repeated use of instrument beyond intended use.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.
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It was reported the plastic inside the tip of the harmonic scalpel came off outside of the patient.The doctor didn't feel the device was cauterizing as it should and upon pulling it out a part of the plastic tip fell off and onto the draperies that were put over the patient.There was no patient injury, medical intervention, and extended procedure time reported was minimal.These are commonly used devices that are readily available.
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