Evaluation summary: post market vigilance (pmv) led an evaluation of three devices.The root cause of the observed condition was determined to be a result of particulate matter; this was identified as a quality issue with a component obtained from a third party supplier and a product improvement has been initiated to track this failure mode.A review of the device history record for the clip appliers indicates the products were 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.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
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