Additional information provided.A review of the device history record indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.One illuminator was returned for evaluation.The illuminator was returned attached in the trocar assembly and had to be removed for the evaluation.The illuminator was visually examined and deemed nonconforming.There was foreign material present along the beginning surface of the cannula needle (distal end).This material appears to be surgical material.The sample was functionally tested as received for fit through the trocar returned with this complaint issue and was found nonconforming.The cannula needle did not fit through the trocar at the location where the foreign material was present.The foreign material was able to be removed with cleaning from the illuminator cannula needle surface and the fit test was performed again.The illuminator fit through the complaint trocar was then deemed conforming.The cannula diameter as received was measured and was deemed nonconforming at the location of the foreign material.The cannula needle diameter was re-measured after cleaning the foreign material from the illuminator cannula needle surface and the diameter was deemed conforming.One trocar cannula/hub assembly was received and visually inspected and was found to be conforming.The sample was then dimensionally inspected for the cannula inner diameter and was found conforming.The sample was then functionally tested for fit with the associated illuminator and was found conforming.No trocar lot number was identified; therefore, lot history and complaint history reviews for the trocar product could not be conducted.The returned trocar sample was found to be conforming.The complaint evaluation of the illuminator does confirm the illuminator complaint sample would not be able to be easily removed from the trocar.The root cause for this inability of the illuminator to fit through a trocar was due to foreign material present on the needle surface.This foreign material appears to be surgical material based on its visual characteristics as observed with many returned complaints having a translucent crystalline and dried tacky foreign material, along with the ability to clean the foreign material from the cannula needle, and the fact that the cannula needle was initially able to fit through the trocar at the beginning of surgery.For some unknown reason enough surgical material accumulated on the cannula surface prior to removing the device from the trocar.No specific action with regard to this complaint was taken because the reason for the complaint issue was due to customer handling.All light guide products are 100% visual inspected during manufacturing to insure a clean needle surface.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action has been taken at this time.The manufacturer internal reference number is: (b)(4).
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