BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRSEAL ACCESS PORT

    MDR report key: 25244605 · Received May 20, 2026

    Report

    Report Number
    MW5188553
    Event Type
    Death
    Date Received
    May 20, 2026
    Date of Event
    December 4, 2025
    Report Date
    May 18, 2026
    Manufacturer
    CONMED CORPORATION
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244753 AIRSEAL ACCESS PORT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ CONMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death