(b)(4).The device was returned to the factory for evaluation on 04/28/2023.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 the dhr/lhr review results, it was determined that there is relation between the batch manufacturing process and the reported failure.The failure mode is being addressed and investigated under maquet's supplier corrective action request (scar) system.The root cause is supplier manufacturing particularly assembly problem.There were no consequences or impact to the patient.
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