Confirmed for use related issue.The sample evaluation confirms sections of the hydrogel coating have stuck together.As reported 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 w/ echo ps positioning system should be hydrated for no more than 1 -3 seconds just prior to laparoscopic placement.The ventralight st w/ 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.Additionally, to date this is the only reported complaint for this production lot of (b)(4) units released for distribution in may, 2018.
|
It was reported that "while preparing the ventralight st mesh w/ echo ps to insert into the abdomen, the or staff rolled the mesh onto the tongs and this was inserted for placement." as reported, the mesh would not unfurl once in the abdomen and seemed to "stick together." this ventralight st mesh with echo ps was removed and another was used successfully to complete the case.There was no patient injury.The staff is reported to be experienced users of the device.In follow up it was reported that the mesh was not hydrated prior to inserting into the abdomen.This was a robotic case and a 12mm trocar was used.
|