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.The clevis did not exhibit any damage or wear marks.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 benign hysterectomy procedure, the customer noted that the tenaculum forceps instrument had a broken cable.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.
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