AIRSEAL ACCESS PORT

Description of Event or Problem

DEAR SIR/MADAM, THIS LETTER IS BEING SENT TO YOU REGARDING AN EVENT THAT OCCURRED ON 12/04/2025 AND WAS REPORTED TO (B)(6). THE REPORTED EVENT WAS THAT DURING INSERTION OF THE INITIAL PORT FOR A DA VINCI-ASSISTED MEDIASTINAL MASS RESECTION PROCEDURE, UPON INSERTING THE FIRST UNSPECIFIED PORT, THE DIAPHRAGM WAS INADVERTENTLY PERFORATED, RESULTING IN A LIVER INJURY AND SUBSEQUENT BLEEDING. THE PROCEDURE WAS CONVERTED TO AN OPEN THORACOTOMY TO CONTROL THE HEMORRHAGE, AND HEMOSTASIS WAS ACHIEVED; HOWEVER, THE TUMOR WAS NOT REMOVED. DESPITE THESE INTERVENTIONS, THE PATIENT ULTIMATELY EXPIRED. FURTHER INVESTIGATION REVEALED THAT THE PORT WHICH INADVERTENTLY PERFORATED THE DIAPHRAGM WAS A THIRD-PARTY AIRSEAL ACCESS PORT. A DA VINCI INSTRUMENT OR ACCESSORY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).