The device was being used during treatment and was returned for evaluation.The lot number for the device was not provided.However, all lots of pn 101425 distributed to the field from when the part number was first inspected (b)(6) 2016) to the complaint occurrence date (b)(6) 2019) were reviewed finding one lot that was related to fit issues between the handpiece and the visualization tool.However, without the lot information, it cannot be determined if the reported product met manufacturing specifications prior to being released for distribution.A complaint history review was performed and found 26 reports of the issue.This issue will continue to be monitored.A relationship between the device and the reported event could be established.The reported event was confirmed.There appeared to be a concentricity issue with the interior of the plate probe prohibiting it from sliding over the long attachment.Therefore, the root cause of the reported event was due to raw material fault/supplier.No containment or corrective actions are recommended at this time.
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