Intuitive surgical, inc.(isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint of "the white plastic insulation on the instrument was damaged.¿ failure analysis found the primary finding of the bipolar yaw pulley thermal damage to be related to the customer reported complaint.The instrument was found to have thermal damage on one side of the bipolar yaw pulley.There was no material missing from the instrument.There was an additional observation not reported by the site and related to the reported issue.The conductor wire on the same side as the thermal damage exhibited insulation thermal damage with the electrical wires exposed.The electrical continuity test was performed and passed.The root cause of this failure is attributed to a component failure.A review of the provided images is consistent with the allegation of a damaged white "plastic insulation." additionally, the instrument conductor wire's insulation was found to be damaged with the electrical wire exposed.A review of the logs showed the fenestrated bipolar forceps instrument (part# 470205-17 / lot# n13210503-0023) was last used on (b)(6) 2021 during a procedure with system sk2922.The fenestrated bipolar forceps instrument has 10 allotted uses and had 3 uses remaining.In addition, a review of the site's complaint history identified no other complaints related to the fenestrated bipolar forceps instrument.This complaint is being reported based on the following conclusion: the fenestrated bipolar forceps instrument had incurred damage to the bipolar yaw pulley and conductor wire's insulation with the electrical wire exposed and was found to have thermal damage on the bipolar yaw pulley and conductor wire's insulation.The initial reported complaint and subsequent failure analysis findings could be related to the potential for electrical discharge at a location other than intended.While there was no patient injury reported, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable.
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