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 jaw was identified to be detached from the hinge.The device was disassembled, and the blade was inspected for cracks with a microscope.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 the doctor was using the harmonic scalpel and it stopped working.The machine indicated to replace the instrument.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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