Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.The instrument was found to have a broken pitch cable at the distal clevis hub.The broken cable segment that contains the crimp was missing from clevis in the clevis.The clevis did not exhibit any damage or wear marks.Other cables at the wrist were not damaged.Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to this reported event.The customer reported complaint does not itself constitute an mdr reportable event; however, the broken pitch cable found during failure analysis suggests that if the malfunction were to recur it could cause or contribute to an adverse event.
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It was reported that during a da vinci-assisted total bening hysterectomy procedure, the tenaculum forceps instrument would not hold jaws closed on tissue.Upon removal and inspection, the customer noted that the pulley cable had broken.While cleaning the instrument, a cable fragment was dislodged from instrument.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.
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