BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D'VINCI SI

    MDR report key: 3240445 · Received July 16, 2013

    Report

    Report Number
    3240445
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    May 22, 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 UNDERWENT A D'VINCI PELVISCOPY, LASER EXCISION OF ENDOMETRIOSIS, D AND C, HYSTEROSCOPY AND CYSTOSCOPY. DISCHARGED IN STABLE CONDITION. SHE LATER DEVELOPED A TEMPERATURE OF 102 DEGREES F, NAUSEA, VOMITING, AND DIARRHEA AND PRESENTED TO ANOTHER HOSPITAL ON (B)(46 2013. THERE SHE HAD A CT THAT SHOWED ON ABSCESS ON HER UTERUS AND POSSIBLY A SMALL TEAR ON HER RECTUM, WAS TREATED WITH IV ANTIBIOTICS AND ADMITTED FOR 2 DAYS. RECTAL TEAR EVALUATED BY GI. SHE WAS DISCHARGED ON ORAL ANTIBIOTICS. PT HAD OUTPT CT WHICH SHOWED ABDOMINAL ABSCESS WAS DRAINING ON ITS OWN, THUS PT DID NOT REQUIRE SURGERY. HOWEVER, PT CONTINUED TO HAVE CONSTANT DIARRHEA, NAUSEA, VOMITING, FEVER, AND PELVIC PAIN, AND WAS READMITTED ON (B)(6) 2013. FOUND TO HAVE ILEUS. WAS NPO AND ON ANTIBIOTICS. ILEUS AND PELVIC INFECTION RESOLVED, AND PT DISCHARGED ON (B)(6) 2013 IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330206 D'VINCI SI D'VINCI ROBOT NAY INTUITIVE SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| S