It was reported that during a da vinci simbryo plasty procedure, a cable detached from one end of the mega suturecut needle driver instrument, and was loose.There was no report of fragments falling into the patient.The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.
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The instrument was returned and evaluated.Per the customer reported complaint, failure analysis investigation found that the grip cable was broken at the distal idlers.The cable segment stuck out at the instrument's wrist.The idler pulley spun freely and did not exhibit any damage.The other cables at the instrument's wrist were intact and undamaged.No other damage was found.The customer reported complaint does not itself constitute a mdr reportable event; however, the broken cable could likely cause or contribute to an adverse event, if the malfunction were to recur.
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