H10: internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.There was a relationship found between the returned device and the reported event.A visual inspection found no issues.A functional evaluation revealed a handpiece sensor fault.A handpiece stall error message appeared when the footswitch was used.Further evaluation revealed a corroded gearbox.No overheating was noted.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was confirmed, and the root cause was associated with corrosion in the gearbox.Factors which can contribute to overheating include a blade stall condition that will result in increased current draw from the control unit which will heat the motor and hand piece housing.This can be the result of gearbox corrosion caused by cleaning and sterilization methods and the chemicals involved the complaint of a handpiece sensor fault was confirmed, and the root cause has been associated with an electrical component failure.Factors that could have contributed to the reported event include a failure of the reed switch or damage on the hall board which may contribute to a short circuit.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.Correction in h6 (medical device problem code).
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