Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure of ¿broken cable¿.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis could cause or contribute to an adverse event if the malfunction were to recur.
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It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, the permanent cautery hook instrument had a broken cable.There was no report of fragments falling inside the patient.The planned surgical procedure was completed and no patient harm, adverse outcome, or injury was reported.
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