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 lines.The electrode has been used.Bio debris is present.Product was out of the original packaging.No packaging returned.A functional evaluation showed the opened device was plugged into the controller and registered settings (0,3).When used with a bypass box the wand was able to generate plasma and coagulation as intended.Saline was drawn and pushed through the waste line showing no clog or slow run.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.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.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.A clinical review states the requested supporting clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the reported event.The patient impact was the increased bleeding.The root cause 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.
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