The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The teflon pad was melted and lifted off the actuating arm.A portion of the teflon pad was detached and returned with the complaint device.The jaw, blade and contact rings appear to be intact.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 - repeated use of instrument beyond intended use - incidental contact with device and external instrument causing damage to the tissue pad 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 harmonic scalpel (har36) tip broke off as they were going to use on patient.The patient was in the room, however, the event occurred prior to use on patient.There was no patient injury, medical intervention, or extended procedure time reported.The device was replaced to successfully complete the procedure.These are commonly used devices that are readily available.
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