Effectiveness check plan: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The clip applier was received partially applied.No visual abnormalities were observed.Functionally, the clip applier was cycled but the clip did not load.The pusher bar was observed to not be functioning properly.A review of the device history record for the clip applier indicates the product was released meeting all medtronic quality release specifications at the time of manufacture.However, a manufacturing fault was identified during product analysis.The root cause of the observed condition was determined to be a result of a manufacturing activity.The trip lever out of position preventing the clips from loading properly.A process improvement has been initiated to prevent this condition from recurring.If information is provided in the future, a supplemental report will be issued.
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