BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI ENDOWRIST GRAPTOR

    MDR report key: 2913010 · Received December 27, 2012

    Report

    Report Number
    2913010
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 12, 2012
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US

    Narratives

    Description of Event or Problem · 1

    TIP OF THE GRASPING RETRACTOR FOR DAVINCI ROBOT WAS FLOPPY AND SURGEON WAS UNABLE TO CONTROL INSTRUMENT WITH ROBOTIC ARM.======================MANUFACTURER RESPONSE FOR GRASPING RETRACTOR, DAVINCI (PER SITE REPORTER).======================MANUFACTURER TO EVALUATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVINCI SI ENDOWRIST GRAPTOR SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420278 M10120919-916

    Patients

    Seq Age Sex Outcome Treatment
    1 *