BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D'VINCI SI

    MDR report key: 3240447 · Received July 16, 2013

    Report

    Report Number
    3240447
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    April 30, 2013
    Report Date
    July 16, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PLEASE NOTE THE 5 CASES BEING REPORTED CONCURRENTLY BY OUR FACILITY HAVE THE D'VINCI ROBOT AS A COMMONALITY; WE ARE NOT IMPLYING THAT IT IS THE CAUSE. OUR FACILITY HAS TWO D'VINCI ROBOTS. WE ARE UNCERTAIN WHICH ONE WAS USED IN THIS CASE. ON (B)(6) 2013, PT HAD D'VINCI PROSTATECTOMY FOR TREATMENT OF PROSTATE CANCER. WHILE UNDERGOING THIS, ADHESIONS NOTICED IN AREA OF APPARENT OLD APPENDECTOMY. SURGEON BROUGHT IN TO DO LAPAROSCOPIC LYSIS OF ADHESIONS. PT DISCHARGED (B)(6) 2013. ON (B)(6) 2013, PT PRESENTED TO ED FOR ABDOMINAL PAIN. CT DONE IN ER CONSISTENT WITH FINDINGS RELATED TO THE PT'S RECENT SURGERY; PT SENT HOME. PT HAD WORSENING GENERALIZED WEAKNESS, RIGHT LOWER ABDOMINAL PAIN, FEVERS AND NAUSEA AND HAD A CT AT ANOTHER FACILITY WHICH RETURNED AS FINDINGS CONSISTENT WITH INTRAABDOMINAL ABSCESS. ON (B)(6) 2013, ADMITTED THRU ER FOR FEVERS AND NEW CT FINDINGS WHICH SHOWED MULTIPLE ABD AND PELVIC ABSCESS COLLECTIONS. IN INTERVEN RADIOLOGY, HAD DRAINAGE OF ABSCESSES AND JPS PLACED. CULTURES OF DRAINAGE GREW OUT LACTOBACILLUS. BLOOD CX NEG. PT IMPROVED CLINICALLY, AND WAS DISCHARGED ON IV ANTIBIOTICS PER PICC LINE, AND ORDERS FOR WEEKLY LABS; DISCHARGED ON (B)(6) 2013 IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330173 D'VINCI SI D'VINCI ROBOT NAY INTUITIVE SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| S