BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SURGICAL SYSTEM

    MDR report key: 1915208 · Received December 6, 2010

    Report

    Report Number
    2955842-2010-00528
    Event Type
    Death
    Date Received
    December 6, 2010
    Date of Event
    August 12, 2010
    Report Date
    November 11, 2010
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K011002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2012, ISI RECEIVED A LEGAL SUMMONS INDICATING THAT THE PATIENT EXPIRED ON (B)(6) 2010, POST OP A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGOO-OOPHORECTOMY AND PELVIC NODE DISSECTION PROCEDURE PERFORMED ON (B)(6) 2010. EMERGENCY SURGICAL PROCEDURES PERFORMED ON THE PATIENT ON (B)(6) 2010, REVEALED THAT THE PATIENT HAD SUSTAINED A BURN TO THE RIGHT EXTERNAL ILIAC ARTERY, PUMPING BLOOD IN THE BODY CAVITY, CAUSING BOWEL ISCHEMIA INCOMPATIBLE WITH LIFE. FOLLOWING THE SURGICAL PROCEDURE, PAIN MEDICATION WAS CONTINUALLY ADMINISTERED TO THE PATIENT WITHOUT GOOD AFFECT DUE TO SIGNIFICANT PAIN EXPERIENCED BY THE PATIENT.

    Additional Manufacturer Narrative · 1

    ON NOVEMBER 30, 2010, AN ISI CLINICAL SALES REPRESENTATIVE SPOKE TO THE SURGEON THAT PERFORMED THE DA VINCI HYSTERECTOMY ON THE PATIENT. THE SURGEON STATED THAT THE PATIENT DID HAVE AN AUTOPSY PERFORMED WHICH FOUND THAT THE PATIENT HAD AN INJURY TO HER LEFT EXTERNAL ILIAC ARTERY. THE SOURCE OF THE INJURY WAS NOT CONFIRMED. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS INDETERMINABLE IF THE DA VINCI SYSTEM, INSTRUMENTS OR ACCESSORIES CONTRIBUTED TO THE PATIENT'S DEMISE. AS OF DECEMBER 3, 2010, NO ADVERSE EVENTS HAVE BEEN EXPERIENCED WITH THE SITE'S SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A SUCCESSFUL DA VINCI HYSTERECTOMY PROCEDURE, THE PATIENT DEVELOPED AN INFECTION AND WAS NOT DISCHARGED AS PLANNED. TEN DAYS POST OP, THE PATIENT WAS GIVEN A BLOOD THINNER AND EXPIRED DUE TO AN ARTERIAL BLEED. REPORTEDLY, THE PATIENT'S DEMISE WAS UNRELATED TO THE DA VINCI SURGICAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS1200 A4.3P9

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Death DA VINCI SYSTEM INSTRUMENTS AND ACCESSORIES