(b)(4).The device was returned to the factory for evaluation on 12/19/2023.A photograph was provided by the account.A photographic inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.The clear silicone insulation of both the hot and cold jaws was observed to be intact with no visual defects.The heater wire was observed to be flexed away from the base of the hot jaw, twisted, and detached from the tip of the jaw.An investigation was conducted on 01/03/2024.A visual inspection was conducted.Signs of clinical use and evidence of blood and charred material were observed on the device.A microscopic inspection was conducted.The clear silicone insulation of both the hot and cold jaws was observed to be intact with no visual defects.The heater wire was observed to be flexed away from the base of the hot jaw, twisted, and detached from the tip of the jaw.Based on the photographic inspection, returned condition of the device, and investigation results, the reported failure "material twisted/bent; wire" was confirmed.The lot # 3000346361 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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