BEUDAMED
    FDA Adverse Event Death Summary report: N

    DA VINCI SI SURGICAL SYSTEM

    MDR report key: 2567858 · Received May 9, 2012

    Report

    Report Number
    2955842-2012-00202
    Event Type
    Death
    Date Received
    May 9, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 9, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K081137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISI CLINICAL SALES REPRESENTATIVE FOLLOWED UP WITH THE ASSISTANT RN AND THE RN INDICATED THAT THE PATIENT SIDE ASSISTANT HAD NOT RECEIVED TRAINING BY THE SITE ON HOW TO PERFORM A GUIDED TOOL CHANGE. BASED ON THE INFORMATION PROVIDED, THE PUNCTURING OF THE PATIENT AORTA IS THE RESULT OF AN INCORRECT INSTRUMENT CHANGE. THE SURGEON HAD REQUESTED THAT INSTRUMENTS LOCATED ON THE PATIENT SIDE MANIPULATORS (PSM) ARMS BE SWAPPED, SUCH THAT THE INSTRUMENT ON PSM ARM 1 WOULD BE SWITCHED WITH THE INSTRUMENT LOCATED ON PSM ARM 2. IT IS NOT CLEAR WHETHER THE ASSISTANT NURSE USED A GUIDED TOOL CHANGE TO SAFELY CHANGE INSTRUMENTS OR WHETHER THE NURSE USED THE ARM CLUTCH TO INSERT THE INSTRUMENT MANUALLY. IT IS UNCLEAR WHETHER ANY MALFUNCTION OF THE SYSTEM OCCURRED AND THE EXACT MECHANISM WHICH RESULTED IN PUNCTURING OF THE AORTA. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION AND ONCE THIS INFORMATION HAS BEEN RECEIVED, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE DA VINCI SI INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: WARNING: THE INSTRUMENT MAY NOT BE IMMEDIATELY VISIBLE WHEN BEING MOVED FROM THE CANNULA INTO THE PATIENT. USE APPROPRIATE CAUTION WHEN MANUALLY INSERTING INSTRUMENTS INTO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 45 MINUTES INTO A DA VINCI SI PROCEDURE WHEN THE ASSISTANT AT THE PATIENT SIDE CART (PSC) PERFORMED A TOOL CHANGE TO SWITCH THE INSTRUMENTS IN THE PATIENT SIDE MANIPULATOR (PSM) ARMS, THE PATIENT'S AORTA WAS PUNCTURED. THE SURGEON MADE THE DECISION TO CONVERT TO TRADITIONAL OPEN SURGICAL TECHNIQUES TO COMPLETE THE PLANNED SURGICAL PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION RIGHT AFTER THE OPEN SURGICAL PROCEDURE, HOWEVER, THE PATIENT EXPIRED THE FOLLOWING DAY. THE SITE HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI SI SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL,INC. IS3000 A6.0P6

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death DA VINCI SI SYSTEM, INSTRUMENTS & ACCESSORIES