H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.An analysis of the customer provided images found the tip of the wand with a melted cord.The root cause has been associated with unintended use of the device.Factors that could have contributed to the failure include improper sterilization technique, rough handling of the device, or exposure of the device to high temperatures.No containment or corrective actions are recommended at this time.
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