Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: unknown.The actual device was not returned for evaluation.Therefore an evaluation of a retention sample from the reported product code/lot number combination was conducted.The sample was taken out of the unit box and visual inspection revealed no defects.A review of the device history record and product release decision control sheet of the involved product/lot# combination was conducted with no relevant findings.The investigation results verified that the retention sample was the normal product.Without the return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.It is possible, as a cause of the reported event, that the actual sample was exposed to shock force during transportation/storage.Ashitaka factory has requested that terumo europe office inquire for this possibility and, as appropriate, instruct their local transport companies thoroughly to handle the products with the best care.(b)(4).
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