Two opened trocar cannula/hub assemblies were received visually inspected and were found to be non-conforming, both are damaged.The damage to the trocar is a compressed appearance.Indentations/tools marks were also visible on the cannulas.Functional and dimensional testing could not be performed due to the damage of the cannulas.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.The probe was not returned.The returned trocar assemblies were found to be visually and functionally non-conforming, therefore a product fit issue as described by the customer was confirmed; however when and how the cannula of the trocar became damaged could not be confirmed and a root cause cannot be determined from the evaluation performed.The tool marks indicate that the trocars were possibly compressed when trying to advance or remove a component from the trocars.The exact root cause for the damaged trocar sample is unknown, therefore specific action with regards to this complaint cannot be taken.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 further actions are required.The manufacturer internal reference number is: (b)(4).
|