(b)(4).Batch # unk.Attempts have been made to retrieve the device.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.A manufacturing record evaluation was performed for the finished device lot number r40c1p, and no non-conformances were identified.Additional information was requested, and the following was obtained: just for clarification, can you please confirm if the device fired malformed or unformed clips? if yes, were they not able to hold onto the vessel they were applied to? or did the clips drop or eject unformed clips from the jaws? r= the device fired malformed clips which were unable to hold on the vessel.
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It was reported that during a discectomy, the surgeon used the ligaclip on a vessel, but the clips didn¿t have strength to grasp and fell out.No delay in the procedure.Opened another ligaclip to complete the case successfully.Fragments were generated and removed easily without intervention.There were no patient consequences.
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