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 the clevis.Missing crimp was approximately 0.046 x 0.032.The clevis did not exhibit any damage or wear marks.A device history record (dhr) review for this device was conducted and did not find any non-conformances that would affect any material of the final product and/or the quality or performance of the instrument.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 failure mode were to recur.
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It was reported that during a da vinci-assisted hysterectomy procedure, one of the wires was popped out on the tenaculum forceps instrument.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.There were no reports of any fragment(s) falling inside the patient.
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