Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: package lot number of the clips? what do you mean by ""the ratchet of the 3 clips did not lock during use.""?- was the issue related to clips? yes.3 clips could not be fixed to the suture.Or was the issue related to applier device component? no.Were the clips able to hold the suture in tissue intra-op? no.If clip did not close/did not hold on the suture, was the clip used in an application where the suture was under tension? no further information is available.Confirm if total qty of 3 clips involved that were reported with issue during use on single procedure/patient? yes.Were the clips able to be loaded on the applier jaws? no further information is available.When the even occurred, was the suture placed near the hinge of the clip? no further information is available.Was the applier checked for damage (jaws straight and aligned)? no further information is available.No further information will be provided.
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