BEUDAMED
    FDA Adverse Event Summary report: N

    DAVINCI

    MDR report key: 2973586 · Received February 15, 2013

    Report

    Report Number
    2973586
    Date Received
    February 15, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A ROBOTIC PROCTOSIGMOIDECTOMY WITH TAKE DOWN OF COLOVAGINAL FISTULA. DURING THE PROCEDURE THE SURGICAL PA NOTICED THAT THE #1 ROBOTIC ARM WAS NOT ACTING RIGHT. SHE STATED THAT WHILE VISUALLY EXAMINING THE AREA AROUND THE ENTRANCE SITE TO SEE IF THERE WAS A PROBLEM, THE ROBOTIC ARM ALL OF A SUDDEN JERKED FORWARD MOVING FURTHER INTO THE PATIENT AND THEN JERKED BACK. IT WAS DESCRIBES AS A STABBING MOTION. THIS CAUSED AN INJURY TO THE AORTIC ARTERY. THE ABDOMEN WAS IMMEDIATELY OPENED AND VASCULAR SURGEON CALLED TO THE ROOM TO ASSIST. AFTER THE REPAIR OF THE VESSEL THE SURGERY CONTINUED. PATIENT WAS TRANSFERRED POST OP TO ICU. AS DOCUMENTED. AFTER THE OCCURRENCE I TALKED WITH THE STAFF IN THE ROOM AND THEN CALLED THE COMPANY SPOKE WITH SOMEONE WITH TECHNICAL SERVICE, OUR SERVICE ENGINEER, AND OUR SALES REPRESENTATIVE. ROBOT SEQUESTERED UNTIL FOLLOW UP WITH EVERYONE IS COMPLETED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ROBOTIC PROCTOSIGMOIDECTOMY WITH TAKE DOWN OF COLOVAGINAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69470 DAVINCI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. ID SH1149 PN 37117-04F

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R