BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVINCI SI ENDOWRIST HOT SHEARS

    MDR report key: 2913001 · Received December 27, 2012

    Report

    Report Number
    2913001
    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

    SCISSOR IS SEPARATING NEAR THE TIP.======================MANUFACTURER RESPONSE FOR MONOPOLAR CURVED SCISSOR, DAVINCI (PER SITE REPORTER).======================MANUFACTURER TO EVALUATE DAMAGE AND REPORT BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DAVINCI SI ENDOWRIST HOT SHEARS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT NAY INTUITIVE SURGICAL, INC. 420179 M11120911-829

    Patients

    Seq Age Sex Outcome Treatment
    1 *