BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTUITIVE SURGICAL

    MDR report key: 3140856 · Received May 28, 2013

    Report

    Report Number
    MW5030353
    Event Type
    Injury
    Date Received
    May 28, 2013
    Date of Event
    August 31, 2010
    Report Date
    May 20, 2013
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RADICAL PROSTATECTOMY USING DA VINCI ROBOT, (B)(6) HOSPITAL. DEVELOPED POST - SURGERY GROIN PAIN THAT REQUIRED WHEEL CHAIR USE. (B)(6) HOSPITAL DIAGNOSED PAIN AS INGUINAL HERNIA ASSOCIATED WITH PROSTATE SURGERY ABOVE. CORRECTIVE SURGERY ON (B)(6) 2011, (B)(6) HOSPITAL IMPLANTED WITH JOHNSON AND JOHNSON ETHICON PROLENE HERNIA MESH. COMPLICATIONS HAVE INCREASED TO INCLUDE NERVE DAMAGE, BOWEL PROBLEMS, SWOLLEN TESTICLE, LEG AND GROIN PAIN, KIDNEY PAIN, FLATULENCE, INCREASED STRESS URINARY INCONTINENCE AND INCREASED BLOOD PRESSURE. VA HAS RULED THIS IS ASSOCIATED WITH HERNIA REPAIR ABOVE, WHICH AS NOTED ABOVE WAS RULED BY VA TO BE ASSOCIATED WITH THE DA VINCI SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233274 INTUITIVE SURGICAL DA VINCI ROBOTIC SURGICAL SYSTEM NAY INTUITIVE SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other