Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint "the wires at the front of the tip have damage (abrasions)." failure analysis found the primary failure of insulation damage on the conductor wire to be related to the customer reported complaint.The insulation damage was located at the distal end on the bipolar yaw pulley.No material was found to be missing.Electrical continuity was tested and passed.Root cause of insulation damage is attributed to a component failure.Failure analysis found the secondary failure of mechanical damage on the bipolar yaw pulley to be related to the customer reported complaint.The instrument was found to have mechanical damage on the bipolar yaw pulley.The location was relative to the conductor wire insulation damage.No material was found missing.Root cause is not established.A review of the instrument log for the maryland bipolar forceps (part # 470172-16 / lot # n12191216 0265) associated with this event has been performed.Per logs, the maryland bipolar forceps was last used on (b)(6) 2020 on system (b)(4), with 2 uses remaining.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.Based on the information provided at this time, this complaint is being reported because a bipolar instrument with damaged conductor wire insulation could lead to inadvertent transmission to tissue other than intended via the exposed conductor wire.While there was no harm or injury to the patient, the reported failure mode identified through failure analysis could likely cause or contribute to an adverse event if it were to recur.While there was no patient harm or injury, the reported failure mode could potentially cause or contribute to an adverse event if it were to recur.
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