BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST MEGA

    MDR report key: 3201754 · Received December 21, 2012

    Report

    Report Number
    3201754
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    INTUITIVE SURGICAL INC
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOWRIST MEGA SYSTEM, SURGICAL, COMPUTER NAY INTUITIVE SURGICAL INC 8MM *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR