H10: h3, h6: the device was being used during treatment and was not returned for evaluation.The lot number for the device was not provided.However, all lots of pn (b)(4) distributed to the field from when the part number was first inspected to the complaint occurrence date 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 similar reports of the issue.This issue will continue to be monitored.A relationship between the device and reported event has not been established.Factors that could have contributed to the reported event is that the plate probe had an incorrect notch curvature.Therefore, this issue prevented the plate probe from fully locking in and it was not machined with sufficient space to allow proper locking with the handpiece.However, without the device for evaluation, the reported event cannot be confirmed.Therefore, the root cause of the reported event could not be determined.
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