Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed investigations.Failure analysis investigations replicated and confirmed the customer reported complaint.The instrument was installed on in-house system and passed the self-check test.The instrument moved intuitively with a full range of motion.The instrument passed cut and seal functional testing with no issues.The instrument passed grip force testing in all wrist orientations and passed electrical continuity testing.The instrument failed gap gage testing; the instrument's gage measured 0.001 indicating that space between the electrodes was below specifications.Review of the instrument's logs for the reported procedure date, found that during use of the instrument, there were 31 incomplete cuts followed by complete cuts.The seals were found to be complete.No other damage was found.Based on the information provided, this complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the endowrist one vessel sealer instrument did not correctly seal the patient's tissue adequately.While there was no harm to the patient, recurrence of the reported failure mode could cause or contribute to an adverse event.
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It was reported that during a da vinci-assisted right hemicolectomy procedure, the endowrist one vessel sealer instrument did not correctly seal the patient's tissue.The planned surgical procedure was completed and there was no report of any patient harm, adverse outcome or injury.
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