BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI ROBOTICS SYSTEM

    MDR report key: 492776 · Received October 21, 2003

    Report

    Report Number
    MW1029863
    Event Type
    Injury
    Date Received
    October 21, 2003
    Date of Event
    October 10, 2002
    Report Date
    October 21, 2003
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE DA VINCI SURGICAL SYSTEM IS CURRENTLY BEING USED FOR MOBILIZATION OF THE INTERNAL MAMMARY ARTERY (IMA) DURING CORONARY ARTERY BYPASS PROCEDURES UNDER FDA CLEARANCE K002489 (ISSUED 2001), AND FOR TOTALLY ENDOSCOPIC CORONARY ARTERY BYPASS PROCEDURES UNDER THE AUSPICES OF IDE # G010011. BASED ON THE INFO PROVIDED, THE EVENT DOES NOT MATCH ANY COMPLAINT RECORDED FOR THE DA VINCI SURGICAL SYSTEM OR ITS INSTRUMENTS, NOR DOES IT MATCH ANY PROCEDURE PERFORMED UNDER THE IDE. THE MEDWATCH REPORT INDICATES THAT THE USER FACILITY WAS NOTIFIED AND INTUITIVE SURGICAL HAS NOT BEEN CONTACTED BY THE FACILITY, LEADING TOTHE CONCLUSION THAT A RELATIONSHIP BETWEEN THE PT CONDITION AND THE DA VINCI SYSTEM USED DURING THE PROCEDURE COULD NOT BE ESTABLISHED BY THE HOSPITAL. COMPANY'S CONCLUSION IS THAT THIS IS NOT AN MDR REPORTABLE EVENT BASED ON THE FOLLOWING: NO DEATH OR SERIOUS INJURY ATTRIBUTED TO THE DEVICE OCCURRED. NO MALFUNCTION OF THE DEVICE WAS REPORTED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    PT UNDERWENT MINIMAL INVASION, ROBOTICS ASSISTED, CORONARY BYPASS SURGERY -LIMA TO LAD-, WITH VERY BAD RESULTS, AND PT WANTS TO BE SURE THAT THEIR SITUATION HAS BEEN REPORTED PROPERLY. FIRST, THE LIMA ARTERY, GRAFTED TO THE LAD, RECLOGGED APPROX. 90% -IN THE AREA WHERE THEY STITCHED-, AND THE LEG VEIN THEY USED AS A BACKUUP, RECLOGGED 100% ALL WITHIN 4 MONTHS. SECONDLY, PT HAS BEEN, AND CONTINUES TO BE IN CHRONIC PAIN, SINCE THE OPERATION, THROUGHOUT THE LEFT SIDE OF THEIR CHEST. PT HAS SEEN TWO PAIN DRS AND IS UNDER THE CARE OF A PAIN DR NOW, AND WAITING FOR A THORACIC EPIDURAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI ROBOTICS SYSTEM * NAY INTUITIVE SURGICAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R| S