Due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation, and there are current controls to mitigate the risk of the as reported event.As per the additional information the device was confirmed to be in good condition during preparation/prior to use on the patient and it was prepared as per the dfu.As the device was not returned for analysis, and a review and analysis of all available information fails to indicate an assignable cause, or a probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.The device is not available to the manufacturer.
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