BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1721314 · Received June 11, 2010

    Report

    Report Number
    2955842-2010-00254
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    August 23, 2009
    Report Date
    September 1, 2009
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE HAS BEEN REMOVED PER FDA REQUEST.

    Additional Manufacturer Narrative · 1

    ON JUNE 11, 2010, A MESSAGE REQUESTING ADDITIONAL INFORMATION REGARDING THE EVENT WAS LEFT AT THE OFFICE OF THE CONSOLE SURGEON. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT PASSED AWAY ON (B) (6) 2009, ELEVEN DAYS AFTER UNDERGOING A UROLOGIC PROCEDURE WITH THE DA VINCI S SURGICAL SYSTEM.

    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 A5.1P8

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death DA VINCI S SYSTEM INSTRUMENTS & ACCESSORIES