One opened 25 (gauge) ga trocar assembly in a tray was received.The sample was visually inspected and was found to be conforming, there was no damage observed on the trocar cannula.The sample was then dimensionally inspected for cannula inner diameter and was found conforming.A functional fit test was performed with the returned blade, and it was found to be conforming.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The returned sample was found to be conforming, therefore a product fit issue as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the trocar was manufactured to specifications.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).
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