Post market vigilance (pmv) led an evaluation of one 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.Visual examination of the trocar assembly revealed the circular and envelope seals were intact.Functionally, the obturator was inserted into the trocar with no binding or difficulty.The obturator locking tabs functioned properly.The instrument was applied to test media; the blade tip penetrated 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 medtronic quality specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.
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