BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 3172013 · Received June 3, 2013

    Report

    Report Number
    3172013
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    INTUITIVE SURGICAL
    Product Code
    NAY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    WHILE IN USE THE BLADE WOULD NOT RETRACT. THE DEVICE WAS REMOVED FROM PT. NO PATIENT HARM.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245298 ENDOWRIST SYSTEM, SURGICAL, COMPUTER CONTROLLED NAY INTUITIVE SURGICAL * S10130110

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR