It was reported that the tip of the harmonic device broke while in use.All parts were retrieved, and the device was replaced.The surgeon was utilizing the harmonic around the metal koh uterine manipulator, which may have impacted the integrity of the harmonic.Multiple attempts were made to obtain additional information.No information was provided regarding patient injury, medical intervention, or extended procedure time.These are commonly used devices that are readily available.
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The device was returned to stryker sustainability solutions for evaluation. upon visual inspection of the received complaint device, evidence of clinical use was identified.The blade was fractured and separated from the device tip.The broken tip was not returned for investigation.Inspection of the fractured blade revealed signs of gouging and outer coating erosion as a result of activating against solid/hard materials.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 cause(s) are: too much force or torque applied to instrument, or grasping/pulling; and/or 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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