Intuitive surgical, inc.(isi) received the device 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 in the clevis; however, the broken segment with crimp was returned with the instrument.No material appeared to be missing.The clevis also 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 evaluation 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 low anterior resection procedure, a torn cable was identified on the cadiere forceps instrument.A backup instrument was used and the planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.
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