BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D'VINCI SI

    MDR report key: 3240434 · Received July 16, 2013

    Report

    Report Number
    3240434
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    March 6, 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 OF THE TWO WAS USED IN THIS CASE. ON (B)(6) 2013, PT UNDERWENT D'VINCI PELVISCOPY WITH LASER DESTRUCTION OF ENDOMETRIOSIS, ALSO HAD CYSTOSCOPY AND PROCTOSCOPY. DISCHARGED. ON (B)(6) 2013, PT HAD CT-GUIDED ASPIRATION OF PELVIC ABSCESS ADJACENT TO R OVARY. DISCHARGED TO HOME. ON (B)(6) 2013, READMITTED, WENT TO OPERATING ROOM: EXPLORATORY LAPAROSCOPY CONVERTED TO OPEN PROCEDURE WITH FINDING OF INFLAMMATION AND ADHESIONS, DENSE INVOLVEMENT OF SMALL INTESTINE WITHIN PELVIS AFFILIATED WITH ABSCESS. ABSCESS DRAINED, LYSIS OF ADHESIONS DONE, AND SMALL BOWEL RESECTED WITH REANASTOMOSIS. DISCHARGED IN STABLE CONDITION ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330509 D'VINCI SI D'VINCI ROBOT NAY INTUITIVE SURGICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization| S