The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.Portion of the teflon pad was identified to be melted and detached from the jaw.The missing piece of the teflon pad was not 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.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 a harmonic shears (harh36) malfunctioned while being utilized in surgery.They attempted to reset machine, clean shears, and tighten shears.However, the device still did not work.Another device was opened to complete the case.The customer reported no patient harm.There was no patient injury, medical intervention, or extended procedure time reported.No other information was provided by the facility.These are commonly used devices that are readily available.
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