BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SURGICAL SYSTEM

    MDR report key: 2250774 · Received September 7, 2011

    Report

    Report Number
    2250774
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    February 3, 2011
    Report Date
    September 7, 2011
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    ROBOT FAILURE AND MALFUNCTION DURING ROBOTIC ASSISTED RADICAL PROSTATECTOMY. INSTRUMENTS ATTACHED TO ROBOT ARM, SURGEON AT CONSOLE WITH NO DIFFICULTIES NOTED. ROBOT DOCKED FOR SURGERY AND DISSECTION BEGUN BY SURGEON. DISSECTION ACCOMPLISHED THROUGH PERIVESICAL SPACE WHEN SYSTEM MALFUNCTIONED FOR APPROXIMATELY 30 MINUTES. TWICE, ROBOT FAILED DURING ADDITIONAL DISSECTION REQUIRING REDOCKING OF ROBOT, TURNING OFF UNIT, AND RESTARTING. SYSTEM FINALLY DID NOT REBOOT AND SURGEON HAD TO SWITCH TO OPEN PROCEDURE.======================MANUFACTURER RESPONSE FOR DAVINCI ROBOT, INTUITIVE DAVINCI (PER SITE REPORTER)======================ROBOT NOTED TO HAVE DEFECTIVE PARTS. PARTS REPLACED INCLUDE:-INSTALLED: PART 650340-13-03 (NO OLD PART REMOVED).-REMOVED: 370967-01 (ASSEMPLY, UIP II MEMBRANE & BACKER, ENGLISH). -REMOVED: 380099-01 (ASSEMBLY, UIP, REMOVABLE). NEW PART INSTALLED.FOLLOWING THIS ACTION, MANUFACTURER NOTED NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVINCI SURGICAL SYSTEM DAVINCI SURGICAL SYSTEM NAY INTUITIVE SURGICAL, INC. IS1000 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR OTHER