Confirmed for use related issue.The sample evaluation confirms for the reported condition of separation of the hydrogel from the mesh.Based on the sample evaluation it appears that the mesh was not hydrated prior to insertion.If the mesh is not hydrated per the instructions-for-use, portions of the hydrogel can become hydrated by bodily fluids during insertion.When this happens the dry portion of the hydrogel barrier will to stick to the hydrated portion making deployment and placement difficult and causing separation of the hydrogel barrier.The sample evaluation found no manufacturing anomalies.Per the instructions-for-use "the ventralight st mesh with echo ps positioning system should be hydrated for no more than 1 -3 seconds just prior to laparoscopic placement.The ventralight st with echo ps positioning system must be rolled immediately after hydration." a review of the manufacturing records was performed, no manufacturing issues associated to the reported event were found in the reviewed lot.All process steps were completed per manufacturing and inspection procedures.Product passed all required inspections at both end product and subassembly levels.There was no rework or other manufacturing abnormalities that may have contributed to this complaint.Additionally, to date this is the only reported complaint for this production lot of (b)(4) units released for distribution in may, 2018.
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