The device was returned to stryker sustainability solutions for evaluation.Visual inspection revealed evidence of clinical use.The blade was identified to be fractured and detached from the device.The detached blade was returned with the complaint device.The jaw, teflon pad 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: - jaws/blade subassembly damage - incidental and prolonged activation against solid surfaces, such as bone or plastic the instructions for use (ifu) state: - use the torque wrench (already mounted to the shaft) to tighten the blade onto the hand piece.Turn the torque wrench clockwise while holding only the gray hand piece until it clicks twice indicating that sufficient torque has been applied to secure the blade.- do not attempt to bend, sharpen, or otherwise alter the shape of the blade.Doing so may cause blade failure and user or patient injury.- avoid contact with any and all other instruments while the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.- note: do not use any other means than the torque wrench to attach or detach the instrument from the hand piece.- note: do not torque the instrument by hand without the torque wrench or damage may occur to the hand piece.The reported event will continue to be monitored through post-market surveillance.
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It was reported the harmonic scalpel worked initially, then stopped working.There was no patient injury, medical intervention, or extended procedure time reported.These are commonly used devices that are readily available.
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