This remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms# (b)(4).A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Four (4) pictures were received.In pictures, it is observed a tube with a small damage in surface of the silicon.No samples were received to perform inspection or testing.A review of the manufacturing process was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.The root cause could not be established.After a review of the different verifications that are performed during the manufacturing process to detect damage components, the most probable root cause is that damaged occurred after the product left the manufacturing facility.As a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.Udi and 510k are unknown.No information available to date.
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