H3, h6: the reported device was received for evaluation.A 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 are signs of arcing between the spacer and metal tube.Product was out of the original packaging.No packaging returned.A functional evaluation showed the opened device was tested and plugged into the controller and registered settings (7,3).The wand was able to generate plasma and coagulation as intended.There were no sparks, arcing, or smoke observed during functional testing.Saline was drawn and returned through the evac line using a syringe with no flow problem.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 could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Factors that can contribute to the complaint event include a failure of a concomitant device.No containment or corrective actions are recommended at this time.H2: corrected data on: h6 (health effect - impact code).
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