It was reported that during use of the insulated tip cautery pencil in a breast augmentation procedure, the patient sustained skin burn within the incision site.General anesthesia was used; however there was no effect on the patient's stability as a result of the incident.The sample has been returned and evaluated including an insulated tip that was not a part of the pre-packaged basin set pack.During sample evaluation, the cautery pencil functioned without an issue on dispersion of heat or current from the cautery blade beyond point of contact.A root cause cannot be determined at this time.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.
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