As reported the assistant did not follow prescribed removal steps.The removal method is described in the products instruction-for-use (ifu) provided with the device.The ifu states, "to deflate the echo ps positioning system, release the clamp on the inflation tube, cut the tube as close to the skin as possible, and then discard the excess tube." begin removal of the echo ps positioning system by grasping one of the two removal points marked by dark arrows adjacent to the bard ® logo.Begin pulling the positioning system off the mesh in one smooth motion.As reported the event occurred due to an error on the part of the assistant, with no malfunction of the device.The information provided by bard 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 bard.Not returned.
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The following was reported to davol: it is reported that during a robotic ventral hernia repair using the ventralight st with echo ps, the mesh was placed and without cutting the inflation tube (as prescribed in the ifu) prior to removing the balloon assembly, the assistant pulled the echo balloon assembly with the grasper at which time the "yellow anchor" detached and became stuck behind the mesh and the abdominal wall.The surgeon removed a suture from the mesh and retrieve the anchor section of the inflation tube.The mesh was re-sutured and case completed.No additional ports were placed and there was minimal delay in the case while retrieving the piece.No other difficulties in the process/procedure were noted to have contributed to the detachment of the device.There was no patient injury.The sample was discarded by the user facility.
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