As reported, the ventralight st w/ echo 2 positioning frame was inadvertently left in the patient following mesh implant; the patient underwent subsequent surgical intervention for the removal for echo 2 ps.Based on the information provided the reported event is determined to be use related with no malfunction of the device as the instructions-for-use were not followed.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for removal of echo 2¿ positioning system frame.The precautions section states ¿visualization must be maintained throughout the course of the entire surgical procedure.Additionally, laparoscopic removal of the echo 2¿ positioning system frame must be performed under sufficient visualization of the entire device and surrounding anatomy, to ensure proper removal.¿ the waring section of the ifu states, ¿discard the echo 2¿ positioning system (including the frame, center hoisting suture, all connectors and mesh introducer) after use.¿ note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Device not returned - remains implanted.
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