It was reported that the controller had a sensor fault in the a port.The shaver could work in port b and in other consoles.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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H10 h3,h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of sensor error message was confirmed.Product failed functional testing with a sensor error in port a only.Product passed functional testing with a known good main pcb installed.Cause of errors is a defective electronic component on the main digital pcb.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
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