Trackwise # (b)(4).The device was returned to the factory for evaluation on 03/25/2021.An investigation was conducted on 04/06/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.Both the connector ends was observed to be intact, no visual defects were observed.A mechanical evaluation was conducted using a reference adaptor, power supply and hemopro 2 device.The cable was able to be connected to the adaptor with no physical or visual difficulties.The reference harvesting device was attached to the cable with no physical or visual difficulties observed.An electrical evaluation was conducted.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2 evh tool, reference adapter and reference power supply set at level 3.0.The device did pass the pre-cautery test.The power supply emitted an audible beeping sound and the evh reference tool produced steam and heat.Based on the returned condition of the device and the results of the evaluation, the reported failure "intermittent continuity" was not confirmed.We cannot confirm the age, sterilization or usage history of this reusable, non-serialized oem device for which the lot number was not provided.The reported device is an oem device, therefore, a lot history review was not applicable.A lot number was not provided and the specific product lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.We cannot confirm the age, sterilization or usage history of this reusable, non-serialized oem device for which the lot number was not provided.
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