Trackwise#: (b)(4).The device was returned to the factory for evaluation on 04/27/2023.An investigation was conducted on 05/10/2023.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There were no visual defects observed.A mechanical evaluation was conducted.The blades were attached to the retractor with no visual or physical difficulties observed.The blade that was attached to the left side of the retractor would not stay attached.An engineer evaluation was conducted.Please see attached engineer evaluation video.Based on the returned condition of the device as well as the evaluation results, the reported failure "mechanical problem" was confirmed.The lot#: 3000293769 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.Based on results of trf 0017, pn: rm7000992, batch: 3000301371 is entered into this ncmr for proper disposition evaluation.
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