Evaluation summary:post market vigilance (pmv) led an evaluation of device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.The obturator and the trocar assembly were received.Visual examination of the trocar assembly revealed the flip top seal was not disengaged.Functionally, the flip top converter did not latch properly.The obturator was inserted into the trocar with no binding or difficulty.The instrument was applied to test media; the knife blade cut cleanly and completely through the media, allowing the cannula to pass through.In addition, the trocar passed the air leak test.A review of the device history record indicates this device lot number was released meeting all quality specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.Replication of the reported condition was due to a component error.The material from the supplier was found to be defective and a product enhancement has been implemented.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.
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