(b)(4).The device was returned for evaluation.Visual inspection confirmed a piece of the plastic packaging bag is stuck to the convex surface of the shell.The device was manufactured in september of 2012.It was verified that the type of low density polyethylene ldpe used to package this device has a propensity to adhere to polished surfaces.The device was used for treatment.This issue has been previously investigated and as part of corrective action, a new supplier for the polyethylene bags has been selected and testing completed to ensure thermal reliability and stability of the new bags.Field action (b)(4) was initiated on january 11, 2016 to remove remaining affected units from the field.This field action contains the related part and lot number.This mdr was identified during an internal retrospective review to meet reporting requirements and therefore is being filed retrospectively.
|