VERESS NEEDLE

Description of Event or Problem

IT WAS REPORTED THAT DURING INITIAL PORT PLACEMENT, BEFORE THE START OF A DA VINCI ASSISTED PROCEDURE, THE PATIENT BECAME UNSTABLE. THIS OCCURRED DURING THE INSERTION OF A VERESS NEEDLE AND SUBSEQUENT INITIATION OF INSUFFLATION. THE PROCEDURE WAS ABORTED, AND THE PATIENT EXPIRED. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).