It was reported that during knee arthroscopy, a little smoke and unpleasant smell from the rear side of the shaver console fan when the power is plugged.The user shut down the console immediately and used another backup console.No significant delay or patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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The reported device, used in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was no relationship found between the returned device and the reported incident.Complaint of smoke could not be reproduced.Product passed functional testing and 6 hour burn-in in enclosed test tower.Smoke did not occur during functional testing on both ports.All functions perform as expected.The complaint was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found related failures.
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