H10 h3, h6: the reported device was received for evaluation.Visual inspection observed the returned instrument shows no manufacturing abnormalities.Fluid is in the fluid line.Electrodes have been used.Bio debris is present.The wand is bent from use.The black shrink wrap is deformed at the distal edge.There is separation between the electrode tip and the shaft with signs of arcing.Product was out of the original packaging.No packaging returned.A functional evaluation showed the device was plugged into the controller and registered settings (7,3).The wand was able to generate plasma and coagulation.There was arcing between the spacer and shaft.The irrigation and suction showed no leaks.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 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.The root cause for arcing was associated with unintended use of the device.Factors that could have contributed to the reported event include contact with metal objects while activating the wand.The root cause for water leakage could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
|