Trackwise#: (b)(4).Corrected sections: h6-- problem code updated to 1069.The device was returned to the factory for evaluation on 07/06/2022.An investigation was conducted on 08/03/2022.Both the cannula and harvesting device were returned.A visual inspection was conducted.Signs of clinical use and evidence of blood were observed on the clear plastic tip of the cannula and c-ring.The c-ring was observed to be cut in half down the center with signs of melting near the flanking curved areas.The scope wash tubing and retention rib remained attached to the cannula.The scope wash tubing and the c-ring remained attached to the cannula due to the presence of a retention rib.No other visual defects were observed.Based on the returned condition of the device, the reported failure "break; c-ring" was confirmed.The lot # 3000242109 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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