The monopolar curved scissors instrument has not been returned to intuitive surgical, inc.For failure analysis evaluation.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.Based on the information provided, this complaint is being reported due to the following conclusion: potential arcing instrument.
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It was reported that during a da vinci-assisted surgical procedure, the cord and endowrist started smoking.The procedure was completed with no reported patient injury nor harm.Intuitive surgical, inc.(isi) made multiple attempts to contact the reporter to obtain additional information about the complaint; however, attempts were not successful.
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