Trackwise id # (b)(4).The device was returned to the factory for evaluation on 09/05/2023.An investigation was conduct on 09/06/2023.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the device.Evidence of charred material was observed between the jaws.The c-ring, heater wire, and gray silicone insulation of the jaws were observed to be intact with no visual defects.A mechanical evaluation was conducted.The blue toggle on the harvesting device was able to manipulate the jaws with no physical difficulties.The toggle could be slid backward to close the jaws and forward to open the jaws.Based on the returned condition of the device and investigation results, the reported failure "mechanical problem" was not confirmed.The lot # 3000316023 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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