The device was not returned to stryker sustainability solutions for evaluation.Received a response from the representative that the facility wants to hold onto the device.As the device was not returned for evaluation, inspection was unable to be performed.A review of the dhr for the reported lot number supports that the device met all inspection and test criteria prior to release from stryker.The reported event could be attributed to: excessive force applied.Contact with hard object or other improper handling.Insufficient structural integrity.Environmental disturbance: shipping/handling damage or extreme conditions.The instructions for use (ifu) state: become familiar with specific model of trocar and cannula prior to employing it in a surgical procedure to avoid damage to patient, to operator or to instrument.Careful handling of instruments is necessary to avoid damage or breakage.Inspect the instruments for any damage.Do not use the instrument if any damage is noted.Return the instrument and packaging to stryker sustainability solutions if it is not in acceptable condition for surgery.The reported event will continue to be monitored through post-market surveillance.Should the device become available for return, the investigation will be reopened.
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