(b)(4).Three pictures of product p/n 870-35kit (22mm dual htd circ kit) were received for analysis.They were visually inspected, finding in one of the pictures a component with tape as is describe in this customer complaint description.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history record review could not be conducted since the lot number was not provided.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.If the device sample becomes available at a later date this complaint will be re-opened.
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