It was reported that during a da vinci-assisted nephrectomy procedure, the user observed that the permanent cautery hook instrument tip "was burned" during intraoperative use.The instrument was replaced with a backup instrument.No fragment fell inside the patient.The customer completed the procedure with no other issue reported.Intuitive surgical, inc.(isi) followed up with the site and obtained the following additional information regarding the reported event: the instrument was inspected prior to use and there wasn¿t any damage or anything out of the ordinary.The instrument did not collide with any other instrument or tool during the procedure.No arcing was observed during the procedure.
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Intuitive surgical, inc.(isi) received the permanent cautery hook instrument involved with this complaint and completed the device evaluation.The reported event was confirmed through failure analysis investigation.Inspection found thermal damage on the monopolar yaw pulley.The conductor wire and its insulation was inspected and no damage was confirmed.The instrument was subjected to testing and passed self-test and the electrical continuity.The known cause of the issue is attributed to mishandling and misuse.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument log for the permanent cautery hook instrument lot# n10210120 / sequence 0075 associated with this event has been performed.Per logs, the instrument was last used for a procedure on (b)(6) 2022 using system sk4412.No logged usage on the reported event date of (b)(6) 2022 on system sk4412.No subsequent use recorded after (b)(6) 2022.A review of the submitted image was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).The following additional information was provided: the image suggests thermal damage to the yaw pulley and distal clevis of the permanent cautery hook instrument.This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.Image analysis of the isi fae identified thermal damage to the yaw pulley and distal clevis of the permanent cautery hook instrument.Evaluation be fa confirmed thermal damage at the monopolar yaw pulley due to mishandling and misuse.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.Blank mdr fields: follow-up was attempted, but the patient information in was either unknown, unavailable, not provided, or not applicable.Device expiration date was left blank as this instrument has 10 usages allotted to it, which are tracked by the da vinci surgical system.The instrument has 3 remaining usable lives, therefore, had not expired.Field is blank because the product is not implantable.Information for the blank fields is not available.Fields are not applicable.
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