Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis confirmed the customer reported failure.For clarification, 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 in the clevis.Missing crimp was approximately 0.046 x 0.032.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 ventral hernia repair procedure, a broken cable was found on the fenestrated bipolar forceps instrument.There was no report of fragment(s) falling inside the patient, patient harm, adverse outcome or injury.
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