Visual examination of the returned bipolar cup confirmed the metal ring was returned assembled and would not move freely within the window.Dimensional evaluation of the cup and metal ring verified that these conformed to print specifications where measured.The metal ring was bent and had damage indicative of impaction of the ring.It was confirmed that attempts to assemble the liner were performed on the back table.Device history record review indicated no deviations or anomalies in the manufacturing process.This reported device is used for treatment.Review of complaint history identified no previous complaints for the part-lot combination associated with the cup.When both tabs are not in the slot, the locking ring will not expand adequately to accept the liner.This can result in, as described in this complaint, difficulty to insert the liner into the bipolar metal shell.With the information provided a likely cause for the reported issue is user not adhering to the instructions provided in the surgical technique.
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