The company representative was able to confirm and replicate the reported event.The reported event is attributed to internal component failure.However, the exact part that was nonconforming remains inconclusive.A substitute machine rental was provided to the customer to complete the surgery.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The root cause of the reported event is attributed to internal component failure in the console.However, the exact part that was nonconforming remains inconclusive.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).
|