It was reported that during a shoulder procedure, the flow rate on the control unit, dyonics 25 was reading 0.3 when the water flow was turned off.When that happens the pressure inside the joint seems high.The procedure was completed without delay using the same device.No patient complications were reported.
|
H3, h6: the reported device was received for evaluation.It was determined the device didn¿t contribute to the reported event.A visual inspection found no issues.A functional evaluation revealed the flow rate was reading 0.3 when the water flow was turned off and the cannula flush valve was opened.However, the flow rate was 0 when the cannula flush valve was closed out.The unit passed all other pressure and functional tests.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failures were documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The instructions for use was 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.Specifically, it includes the following precautions: "during normal use, the flush valve should remain completely closed to ensure accurate pressure control.Failure to completely close the flush valve may result in overpressurization of the joint." the complaint was not confirmed.Please refer to the operations/service manual for troubleshooting guidance if poor or erratic pressure performance is observed.No containment or corrective actions are recommended at this time.
|