Trackwise#: (b)(4).Corrected sections: d4: lot corrected from "3000319625" to "3000288361." the device was returned to the factory for evaluation on 08/07/2023.An investigation was conducted on 09/06/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.Charred material was observed on the intact heater wire.There were no visual defects observed on the intact clear silicone insulation on both the cold and hot jaws.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference cable, adapter and reference power supply at level 3.0.The device did turn on and an audible sound was heard when activating the toggle.The device passed the pre-cautery test.It produced visible steam and heat during ten (10) 3-second activations.The device was tested for the safety shut down system as the device would turn on, and produced visible steam.An activation and transection capability test was performed over four (4) repetitions using "max life test method stm2048073 rev aa.The device successfully transected tissue four (4) times.The jaws were gently cleaned of debris and char with a saline and gauze pad as indicated in the direction for use (cv000008979).A temperature and resistance test was conducted to evaluate the device function per hemopro 2 final test 90523436 rev w.The resistance value was measured at.69 ohms which is within specification.The device passed the temperature measurements test.The displayed temperature increased and turned green within the 2 second specified timeframe.Based on the returned condition of the device as well as the evaluation results, the reported failure "intermittent continuity" was not confirmed.The lot#: 3000288361 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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