H10: the device was being used during treatment and was returned for evaluation.The plate probe fit over all of the handpieces without issue.The serial 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 (4/25/2016) to the complaint occurrence date (6/21/2019) 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 similar reports of the issue.This issue will continue to be monitored.A relationship between the device and the reported event could be established.Functional evaluation of the plate probes found that they fit over the handpieces without any issues.There was no problem found.There is not enough information to determine factors that could have contributed to the reported issue.
|