The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, an indentation in the teflon pad and evidence of clinical use was identified.The blade was identified to be fractured and detached from the device.The blade was cleaned and examined closer under a scope revealing signs of gouging near the break 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 causes are: - jaws/blade subassembly damage.- incidental and prolonged activation against solid surfaces, such as bone or plastic.The instructions for use (ifu) state: - avoid contact with any and all metal or plastic instruments or objects when the instrument is activated.Contact with staples, clips or other instruments while the instrument is activated may result in cracked or broken blades.- incidental and prolonged activation against solid surfaces, such as bone, may result in blade heating and subsequent blade failure, and should be avoided.- close the trigger.Remove the torque wrench by sliding it off of the shaft.Do not dispose of the torque wrench until the procedure is completed.The torque wrench is used to remove the instrument from the hand piece following the procedure.Dispose the torque wrench only after completing the procedure.Note: take care to avoid damage to the blade and clamp arm by closing the trigger while sliding the torque wrench onto or off of the shaft.Note: take care to avoid injury from the blade tip while sliding the torque wrench onto or off of the shaft.The reported event will continue to be monitored through post-market surveillance.
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It was reported that the rod broke off the harmonic scalpel inside the patient.The broken piece was immediately retrieved and the device was replaced.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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