As reported, the echo ps portion of the ventralight st w/ echo ps device was inadvertently left in the patient following mesh implant; the patient underwent subsequent surgical intervention for the removal for echo ps.Based on the information provided the reported event is determined to be use related as the instructions-for-use were not followed.Per the instructions-for-use, supplied with this device, "once initial mesh fixation is complete, the echo ps positioning system is completely removed from the body.The echo ps positioning system (including the balloon, all connectors, and inflation tube) is to be removed from the patient and appropriately discarded as it is not part of the permanent implant." review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in august, 2021.Not returned - sample discarded.
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As reported, on (b)(6) 2022 during a ventral hernia repair procedure using a bard/davol ventralight st mesh w/ echo ps.As reported, when the case was completed, the or circulator identified that the echo ps was not removed from the patient.As reported, the patient was taken back into the or and the echo ps was removed without any further issue.
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