Trackwise id # (b)(4).The lot # 3000246880 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.The device was returned to the factory for evaluation on 08/05/2022.An investigation was conducted on 08/15/2022.A visual inspection was conducted.Signs of clinical use and slight evidence of charred material was observed on the heater wire.The heater wire was observed to be intact, with no visual defects observed.The gray silicone insulation on both the cold and hot jaws was observed to be intact, with no visual defects observed.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu cv000006999) with a reference cable and reference power supply vh-3010 at level 2.5.The device passed the pre-cautery test; it did produce visible steam during several activations over a period of 10 minutes but shut off when the toggle was released.No excess smoke was observed.The pre-cautery test was repeated 5 times while the cable connections were manipulated with the no failure observed.Based on the returned condition of the device as well as the evaluation results, bot the reported failures "electrical/electronic property problem" and "environmental particulates; smoke" were not confirmed.
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