The devices were being used during treatment and were returned for evaluation.The plate probes fit over all of the handpieces without issue.The serial 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 ((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.A complaint history review was performed and found 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.A factor that could have contributed to the issue is if there was debris caught between the handpiece and visualization tool, preventing it from being fully locked in.However, there was no problem found.No containment or corrective actions are recommended at this time.
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