It was reported that a patient underwent a laproscopic procedure with a endopath xcel bladeless optiview technology w/stability sleeve and the physician noted tissue debris inside the device.The device was returned loose inside a zipper-sealed plastic bag, removed from its original packaging.The tray form was not returned but the shipment included the tyvek lid with a label attached.A review of the device history record (dhr), identified by the lot number on the label, found the device passed all visual criteria, both pre and post-sterilization, prior to being shipped to the customer.No discrepancies are observed upon review of the dhr.Though the device had been removed from its sterile packaging and it was unclear what environment it had been handled within, it was examined under magnification for cleanliness, discoloration, nicks, etc.There was no observed foreign matter either attached or loose to the exterior or interior of the obturator's tip or any other part of the obturator.The distal tip appears in good visual condition.There is no confirmation of any foreign matter on or in the device.Manufacturers ref.No.: (b)(4).
|