H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, risk management review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.This case reports, after an ent surgery with the evac 70 xtra wand, the patient experienced postoperative snoring and a subsequent revision pharyngoplasty.It has been communicated that, ¿no further complications were reported.¿ smith and nephew has not received the requested patient specific documentation, the device, and/or adequate materials to fully evaluate the root cause of the complaint.Patient impact beyond that which was reported could not be determined.The patient¿s current health status is unknown.If additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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