It is unknown if the device was in use on a patient.A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The dhr (device history record) review showed that there were no issues related to functional issues neither on the product nor its components during the manufacture of the material.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.The customer complaint cannot be confirmed based only on the information provided, in order to perform a proper investigation it is necessary to evaluate the sample involved on the incident.If defective sample becomes available at a later date this complaint will be re-opened.
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