The device subject of the reported event was returned and evaluated; it was found that the hypo tube in the handle assembly of the lariat snare was bent in two places.The damage found in the hypo tube is indicative of the user applying too much force or speed while trying to advance the handle to open the device.The instructions for use (ifu 731965) provided with the device gives the following information that may cause the device to not function properly: "advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or actuating the device when the handle is at an acute angle in relation to the sheath." the device history record was reviewed, and no abnormalities were noted.The complaint log was reviewed, and this is an isolated event.Steris endoscopy offered in-service training on the proper use of the lariat snare; however, the user facility declined.No additional issues have been reported.
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