(b)(4) received the instrument associated with this complaint and completed its evaluation.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.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 the reported event.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 malfunction were to recur.
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