BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 1850589 · Received October 1, 2010

    Report

    Report Number
    2955842-2010-00420
    Event Type
    Death
    Date Received
    October 1, 2010
    Report Date
    September 3, 2010
    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

    THE HOSPITAL HAS BEEN CONTACTED ON SEVERAL OCCASSIONS TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, COMPLETE EVENT DETAILS AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED TO INTUITIVE SURGICAL. NO MALFUNCTIONS OF THE DA VINCI SI SURGICAL SYSTEM WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST A DA VINCI SI HYSTERECTOMY PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND WAS FOUND TO HAVE SEPSIS. THE PATIENT HAD A DO NOT RESUSCITATE (DNR) ORDER ON FILE AND EXPIRED ONE WEEK LATER. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SI SURGICAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P4

    Patients

    Seq Age Sex Outcome Treatment
    1 Death DA VINCI SI SYSTEM INSTRUMENTS, ACCESSORIES & ESU