(b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and slight evidence of blood and charred tissue was observed on the heater wire.A microscopic inspection was conducted.It was observed that the heater wire was slightly flexed away at the center of the hot jaw, but remained attached at the base and tip of the jaw.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.During the pre-cautery test, it produced steam and audible beeping sound during five (5) 3-second activations.To evaluate the safety shut down system, a poly-fuse activation test was performed 5 times over 10 minutes.The device shut off after the period of sustained activation and reactivated after a 10-second cooling period with no incident each time.An activation and transection capability test were performed over five (5) repetitions using "max life test method.The device activated and transected tissue five (5) times with no cautery failure observed.The jaws were cleaned per the ifu and the pre-cautery test repeated.No smoke and/or steam which could be considered excessive were observed.A temperature and resistance evaluation was conducted to evaluate the device function.The resistance value was measured at 0.675 ohms which is within hemopro 2 final test specification.The device passed the temperature measurement test.The displayed temperature increased and turned ¿green¿ within the 2 second specified timeframe.The displayed temperature decreased once the toggle switch was released.We were unable to reproduce any electrical failure.Based on the returned condition of the device and the results of the investigation, the reported failure modes "failure to cut," was not confirmed.The analyzed failure mode "bent wire" was confirmed.Specific actions for the analyzed failure mode are being maintained and documented under maquet¿s failure investigation report (fir) system.
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