BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 3283208 · Received August 12, 2013

    Report

    Report Number
    2955842-2013-03025
    Event Type
    Death
    Date Received
    August 12, 2013
    Date of Event
    July 12, 2013
    Report Date
    August 1, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL INC. (ISI) HAS ATTEMPTED TO CONTACT THE SITE TO OBTAIN ADDITIONAL INFORMATION CONCERNING THE REPORTED EVENT; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS OF THE DATE OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. ISI HAS REVIEWED THE SYSTEM LOGS FOR THE SITE WITH A PROCEDURE DATE OF (B)(6) 2013. NO SYSTEM ERRORS WERE FOUND TO HAVE OCCURRED DURING THE REPORTED SURGICAL PROCEDURE. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT THE PATIENT WHO UNDERWENT A DA VINCI SI SURGICAL PROCEDURE PASSED AWAY POST-OPERATIVELY. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF A MALFUNCTION OF THE DA VINCI SI SYSTEM, AN INSTRUMENT, OR AN ACCESSORY OCCURRED DURING THE SURGICAL PROCEDURE. IT IS ALSO UNKNOWN IF THE DA VINCI SI SURGICAL SYSTEM CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A DA VINCI SI MITRAL VALVE REPAIR PROCEDURE ON (B)(6) 2013, EXPIRED POST-OPERATIVELY. A SURGEON WHO WAS PART OF THE CARDIAC TEAM AT THE SITE INFORMED AN INTUITIVE SURGICAL INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) THAT THE SURGICAL PROCEDURE WAS ABANDONED SINCE THE PATIENT DEVELOPED PULMONARY EDEMA. NO FURTHER CLINICAL INFORMATION WAS PROVIDED ABOUT THE PROCEDURE OR ABOUT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386697 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P7

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES