Intuitive—da Vinci Xi SureForm 60 Stapler Reloads: Manufacturing Variation May Result in Failure to Deploy Three Individual Adjacent Staples, Potentially Resulting in Incomplete Staple Line

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In a July 1, 2019, Field Safety Notice Urgent Medical Device Recall letter submitted by ECRI Institute member hospitals, Intuitive states that a manufacturing variation identified during internal testing may cause the above reloads not to deploy three individual adjacent staples, which could result in an incomplete staple line. Intuitive also states that the likelihood of this manufacturing variation is low. Intuitive further states that in if a surgeon identifies any missing staples following the use of an affected reload, there may be a minor delay in the procedure to reinforce the staple line with suture or an additional reload. Intuitive also states that if an incomplete staple line is not identified and addressed immediately, the risk is dependent on the type of tissue being stapled. In rare situations, there is a possibility that this could lead to an...