One opened trocar assembly was received in a tray for the report of a damaged trocar blade and unable to insert into the eye.The sample was visually inspected and was found to be nonconforming with a damaged tip and a damaged cutting edges.Penetration testing could not be performed due to the damage of the sample.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The exact root cause could not be determined from the investigation performed.The damage to the returned sample is consistent with damage that can occur when the blade contacts a hard surface such as the protective cap, improper handling, or contact with another instrument during surgery or set-up.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Any nonconformances, such as damaged tip and damaged cutting edges are removed from the lot and scrapped.The manufacturer internal reference number is: (b)(4).
|