As reported, during an unspecified procedure, the ventralight st w/echo 2 positioning system was left inside the patient¿s body.It was reported that another surgeon noted the device and agreed to remove the echo ps.As reported under imaging the device appears to be metallic.Contact reports the patient has pain and mobility issues and is concerned about having an mri performed.
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As reported, the echo 2 ps portion of the ventralight st w/ echo 2 positioning system was inadvertently left in the patient following mesh implant.It is reported that the patient will require subsequent surgical intervention for removal of the echo 2 ps.Based on the information provided the reported event is determined to be use related as the instructions-for-use were not followed.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Per the instructions for use (ifu) supplied with this device, "ventralight¿ st mesh is the only permanent implant component of the device.The echo 2¿ positioning system (which includes deployment frame, center hoisting suture and all connectors) must be removed from the patient and appropriately discarded.It is not part of the permanent implant." note, the date of event provided is a best estimate based on the date of awareness of the reported event.Not returned - remains implanted.
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