BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1020383 · Received March 26, 2008

    Report

    Report Number
    2955842-2008-00160
    Event Type
    Death
    Date Received
    March 26, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 21, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON MARCH 5, 2008, INTUITIVE SURGICAL SPOKE TO THE VICE PRESIDENT OF QUALITY MANAGEMENT AT THE ACCOUNT REGARDING THE INCIDENT. THE VICE PRESIDENT OF QUALITY MANAGEMENT PROVIDED A LETTER MARCH 12, 2008, STATING THAT THE PATIENT'S PREVIOUS MEDICAL HISTORY AND ANATOMY CONTRIBUTED TO THE PT'S DEATH. NO MALFUNCTION OF THE SYSTEM WAS ALLEGED BY THE HOSPITAL. THE HOSPITAL HAS CONTINUED TO USE THE DA VINCI S SYSTEM TO PERFORM SURGERY ON PATIENTS.

    Description of Event or Problem · 1

    ON MARCH 5, 2008, INTUITIVE SURGICAL WAS NOTIFIED PER A CUSTOMER PROVIDED LETTER: "THIS GENTLEMEN WAS DIAGNOSED WITH SEVERE MITRAL REGURGITATION. HE WAS ORIGINALLY EVALUATED FOR POSSIBLE CANDIDACY FOR TRANSMITRAL PERCUTANEOUS REPAIR. HE WAS TURNED DOWN DUE TO MITRAL ANATOMY. THE PT WAS REFERRED HERE FOR POSSIBLE ROBOTIC INTERVENTION AND AGREED TO PROCEED WITH THE SURGERY. INCIDENTLY, THE PT HAD A TEE WHICH REVEALED A VERY CALCIFIED VALVE WITH SEVERE MITRAL VALVE REGURGITATION AND FAIR OVERALL EJECTION FRACTION ABOUT 50%. THE PROCEDURE WAS PERFORMED ROBOTICALLY, INITIALLY WITH FAILURE OF THE MITRAL VALVE REPAIR NECESSITATING FURTHER BYPASS AND MITRAL RING ANNULOPLASTY, WHICH ALSO FAILED-NECESSITATING MITRAL VALVE REPLACEMENT. MULTIPLE TRANSFUSIONS WERE GIVEN INTRAOPERATIVELY (PRBC, 16 UNITS, PLASMA-14 UNITS, CRYO-40 UNITS, PLATELETS-90 UNITS). THE PT WAS IN THE OPERATING ROOM FROM 8:30AM-12 MIDNIGHT. ULTIMATELY, THE PT DEVELOPED LOW CARDIAC OUTPUT, CARDIOGENIC SHOCK AND UNCONTROLLABLE BLEEDING DIATHESIS. DEMISE AT 16:35."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS2000 A5.1P2

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death DA VINCI S SURGICAL SYSTEM INSTRUMENTS| ACCESSORIES