The device was returned to stryker sustainability solutions for evaluation.Upon visual inspection of the received complaint device, evidence of clinical use including biological material and an indentation in the teflon pad was identified.The blade showed signs of grasping/activation against a solid object.The blade was inspected under a microscope and a fracture was found on the distal blade area.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, metal 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.The reported event will continue to be monitored through post-market surveillance.
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It was reported that while the harmonic scalpel was plugged into the generator, the machine stopped working and would not recognize the device.It was also reported the control buttons were not working or would get stuck.There was no patient injury, medical intervention, and extended procedure time reported was minimal.These are commonly used devices that are readily available.
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