H3, h6: the reported device was received for evaluation.A visual inspection found that the returned instrument showed no manufacturing abnormalities.The electrode had been used.Bio debris was present.Product was out of the original packaging and no packaging was returned.A functional evaluation revealed that the controller generated an e7 error when the wand was connected.When used with a bypass box, coagulation and plasma was generated as intended.The resistance measured at 1.05 kilo ohms.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 has been associated with reuse of a single use device.Factors that could have contributed to the failure include previous use or connecting and disconnecting the wand from the controller after power has been turned on.No containment or corrective actions are recommended at this time.
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