H10: h3, h6: the reported device, used in treatment, was received for evaluation.There was not a relationship found between the returned device and the reported incident.A complaint history review concluded this was an isolated event.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.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.A review of risk management files found that the reported failure was documented appropriately.A review of the customer provided images found labelling that confirmed the product identification information.The device is in its packaging, the device has not been deployed, and there is debris on the shaft of the device.A visual inspection found biomatter on the device.A functional evaluation revealed the slide functions properly.The complaint was not verified, 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.No containment or corrective actions are recommended at this time.
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