On 6/14/2020, intuitive surgical, inc.(isi) completed its evaluation of the permanent cautery spatula instrument.Failure analysis (fa) confirmed the customer reported issue as the instrument was found to have thermal damage on the distal clevis.Fa removed the clevis ear and no conductor wire insulation damage or broken conductor wire was observed at the weld.The instrument passed the electrical continuity test and was found to have 2 lives remaining based on the logs.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A log review was performed for the permanent cautery spatula reported in this complaint (pn: (b)(4)) and the following was found: per logs, the instrument was last used on (b)(6) 2020 on system sh2073, with 2 uses remaining.The permanent cautery spatula instrument allegedly ¿short circuited¿ (i.E.Potentially arced) with no evidence or claim of user mishandling or misuse.This complaint is being reported because there was evidence of thermal damage on the distal clevis.Thermal damage on the distal clevis is evidence of electrical discharge at a location other than intended.While there was no harm or injury to patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.This report has been generated in response to fda inspectional observations dated 06-mar-2020.
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It was reported that during a da vinci-assisted wedge resection procedure, performed on (b)(6) 2018, there was a "short circuit" with the permanent cautery spatula (pcs) instrument.The surgical staff completed the procedure and there was no reported patient injury.Intuitive surgical, inc.(isi) completed customer follow-up and obtained the following information: the customer is unable to provide any additional narrative regarding the event.The customer indicated that the surgical staff routinely checks instruments prior to insertion and checks cannulas with the gage pins.Additional patient-related information was also requested, but was unavailable.
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